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PPARγ Agonist Treatment for Cocaine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02774343
Recruitment Status : Completed
First Posted : May 17, 2016
Results First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cocaine Use Disorder
Alcohol Use Disorder
Interventions Drug: Pioglitazone
Drug: Placebo
Behavioral: Therapy
Behavioral: Contingency Management
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Period Title: Overall Study
Started 15 15
Received at Least One Capsule 12 14
Completed 9 12
Not Completed 6 3
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management Total
Hide Arm/Group Description

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
48.3  (7.1) 47.4  (7.8) 47.8  (7.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
4
  26.7%
4
  26.7%
8
  26.7%
Male
11
  73.3%
11
  73.3%
22
  73.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15
 100.0%
15
 100.0%
30
 100.0%
1.Primary Outcome
Title Craving as Assessed by the Brief Substance Craving Scale (BSCS)
Hide Description The brief substance craving scale (BSCS) is a 16-item, self-report instrument assesses craving for cocaine and other substances of abuse over a 24 hour period. The domains of intensity, frequency, and duration are recorded on a five-point Likert scale. The range of scores for each domain is 0 to 4, and the total score is the sum of all three domains. The total score range is 0 to 12, and higher scores indicate higher craving (worse outcome.)
Time Frame Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 5.57  (2.47) 6.23  (3.30)
week 1 5.00  (3.36) 5.08  (3.06)
week 2 4.42  (2.11) 2.91  (2.55)
week 3 4.00  (3.33) 3.82  (3.89)
week 4 4.00  (3.16) 3.18  (2.75)
week 5 2.60  (2.55) 3.82  (2.79)
week 6 3.22  (2.78) 3.45  (3.39)
week 7 2.12  (1.64) 4.36  (3.14)
week 8 3.25  (2.12) 3.55  (2.38)
week 9 2.88  (2.53) 3.82  (3.25)
week 10 2.56  (2.55) 3.36  (2.98)
week 11 2.89  (2.62) 3.82  (2.56)
week 12 2.00  (2.39) 3.55  (2.88)
2.Primary Outcome
Title Craving as Assessed by the Obsessive Compulsive Drug Use Scale (OCDUS)
Hide Description The obsessive compulsive drug use scale (OCDUS) measures the level of craving for cocaine during the past week. The mean score over all time points is reported in this outcome measure (i.e., a summary score is reported). The scale was administered once weekly. It consists of 12 items. The score range is 0 to 60, and higher scores indicates greater craving.
Time Frame Weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.1  (3.5) 21.36  (8.7)
3.Primary Outcome
Title Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving
Hide Description Every two weeks, visual analog scale ratings of craving (VAS craving) consisting of 100 mm line, anchored by 0 "not at all" and 100 "extremely," were used to assess cocaine craving right now, craving on average in the past week, and the worst craving in the past week. Data were analyzed as a total score, which is the sum of the scores for the three questions.
Time Frame Baseline, week 2, week 4, week 6, week 8, week 10, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 57.50  (22.83) 52.29  (29.49)
week 2 53.76  (23.10) 40.31  (29.38)
week 4 37.93  (22.30) 35.58  (29.00)
week 6 21.75  (22.97) 29.86  (31.27)
week 8 25.70  (23.34) 35.88  (34.20)
week 10 18.33  (24.38) 31.42  (35.61)
week 12 15.38  (28.91) 27.86  (30.20)
4.Primary Outcome
Title Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Posterior Thalamic Radiation)
Hide Description DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: DTI Fractional Anisotropy (FA) value
baseline 542.27  (24.60) 546.26  (27.02)
week 12 546.84  (32.79) 535.14  (27.61)
5.Primary Outcome
Title Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Anterior Thalamic Radiation)
Hide Description DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: DTI Fractional Anisotropy (FA) value
baseline 518.20  (24.42) 530.31  (26.28)
week 12 522.40  (30.85) 523.00  (36.46)
6.Primary Outcome
Title Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Splenium of Corpus Callosum)
Hide Description DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: DTI Fractional Anisotropy (FA) value
baseline 645.49  (48.82) 635.81  (26.26)
week 12 655.41  (26.73) 620.98  (35.51)
7.Primary Outcome
Title Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Genu of Corpus Callosum)
Hide Description DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: DTI Fractional Anisotropy (FA) value
baseline 566.66  (44.18) 562.52  (29.34)
week 12 575.06  (30.78) 547.15  (37.45)
8.Primary Outcome
Title Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - External Capsule)
Hide Description DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: DTI Fractional Anisotropy (FA) value
baseline 420.68  (22.35) 418.71  (15.92)
week 12 423.91  (17.23) 418.25  (16.98)
9.Primary Outcome
Title Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Cingulum)
Hide Description DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 8 10
Mean (Standard Deviation)
Unit of Measure: DTI Fractional Anisotropy (FA) value
baseline 465.06  (22.35) 463.91  (15.92)
week 12 471.40  (17.23) 465.75  (16.98)
10.Secondary Outcome
Title Feasibility - Subject Retention as Assessed by Number of Participants Who Completed All 12 Weeks of the Study
Hide Description [Not Specified]
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
12
  80.0%
11
  73.3%
11.Secondary Outcome
Title Feasibility - Medication Compliance as Assessed by Percentage of Urine Samples That Were Riboflavin-Positive
Hide Description Riboflavin was added to pill capsules as a marker of medication compliance. The percentage over all time points is reported in this outcome measure. Urine samples were collected once weekly.
Time Frame weeks 1 - 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 12 14
Mean (Standard Error)
Unit of Measure: percentage of urine samples
96.2  (0.055194) 95.4  (0.055987)
12.Secondary Outcome
Title Feasibility - Medication Compliance as Assessed by Percentage of Self-reports That Indicate Capsules Were Taken
Hide Description A modified Timeline Followback (TLFB) procedure was used for self-reports. The percentage over all time points is reported in this outcome measure. Self-reports were collected once weekly.
Time Frame weeks 1 - 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 12 14
Mean (Standard Error)
Unit of Measure: percentage of self-reports
84.1  (0.105562) 86.9  (0.090174)
13.Secondary Outcome
Title Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects
Hide Description [Not Specified]
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 12 14
Measure Type: Count of Participants
Unit of Measure: Participants
drowsiness
0
   0.0%
1
   7.1%
not sleeping well
2
  16.7%
1
   7.1%
headache
0
   0.0%
1
   7.1%
nervousness
0
   0.0%
2
  14.3%
blurry vision
0
   0.0%
2
  14.3%
dizziness
0
   0.0%
1
   7.1%
nausea
0
   0.0%
1
   7.1%
vomiting
1
   8.3%
1
   7.1%
diarrhea
2
  16.7%
1
   7.1%
stomach pain
3
  25.0%
2
  14.3%
muscle aches
0
   0.0%
1
   7.1%
shortness of breath
0
   0.0%
1
   7.1%
cough
4
  33.3%
1
   7.1%
increased urination
4
  33.3%
1
   7.1%
change in sexual function
1
   8.3%
1
   7.1%
weakness
0
   0.0%
1
   7.1%
fatigue
1
   8.3%
0
   0.0%
difficulty walking
1
   8.3%
0
   0.0%
fever or chills
0
   0.0%
2
  14.3%
loss of appetite
0
   0.0%
1
   7.1%
confusion
0
   0.0%
1
   7.1%
cloudiness
0
   0.0%
1
   7.1%
memory loss
1
   8.3%
0
   0.0%
14.Secondary Outcome
Title Feasibility - Tolerability as Assessed by Number of Participants With Serious Adverse Events
Hide Description [Not Specified]
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 12 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Cocaine Use as Assessed by Percentage of Urine Samples That Were Cocaine-positive
Hide Description The mean percentage over all time points is reported in this outcome measure. Urine samples were collected once weekly.
Time Frame Weeks 1-12
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
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Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: percentage of urine samples
44  (0.34) 50  (0.4)
16.Secondary Outcome
Title Cocaine Use as Assessed by Percentage of Self-reports That Indicate Cocaine Use
Hide Description A modified Timeline Followback (TLFB) procedure was used to assess cocaine use. The mean percentage over all time points is reported in this outcome measure. Self-reports were collected once weekly.
Time Frame Weeks 1-12
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Hide Arm/Group Description:

Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: percentage of self-reports
35  (0.3) 29  (0.28)
Time Frame 12 weeks
Adverse Event Reporting Description Side effects are listed in Outcome Measure 13 are side effects; however, side effects were not considered to be adverse events.
 
Arm/Group Title Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
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Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

Placebo: Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance

All-Cause Mortality
Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/14 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pioglitazone + Therapy + Contingency Management Placebo + Therapy + Contingency Management
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/14 (0.00%) 
Small sample size; restricted measurement battery; comorbid CUD & AUD; single dose; for DTI, Bayesian parameter estimates of variance in the simple effects may be underestimated; generalizability of pioglitazone to other substances of abuse unknown.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joy M. Schmitz, PhD
Organization: The University of Texas Health Science Center at Houston
Phone: 713-486-2867
EMail: Joy.M.Schmitz@uth.tmc.edu
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Responsible Party: Joy Schmitz, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02774343    
Other Study ID Numbers: HSC-MS-12-0421
P50DA009262 ( U.S. NIH Grant/Contract )
First Submitted: May 6, 2016
First Posted: May 17, 2016
Results First Submitted: December 6, 2017
Results First Posted: April 26, 2018
Last Update Posted: April 26, 2018