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Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade

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ClinicalTrials.gov Identifier: NCT01822132
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : February 6, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
P. Todd Korthuis, MD, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Other
Conditions Methamphetamine Abuse
HIV
Interventions Drug: Extended release naltrexone
Drug: Placebo
Enrollment 76
Recruitment Details  
Pre-assignment Details After consenting, 13 participants did not meet screening inclusion criteria and were removed from the study and 11 participants withdrew, leaving 52 eligible participants for randomization into a treatment group (Naltrexone or Placebo)
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description One dose of intramuscular injection of 380mg extended-release naltrexone. One dose of intramuscular injection of placebo.
Period Title: Overall Study
Started 25 27
Completed 21 25
Not Completed 4 2
Reason Not Completed
Lost to Follow-up             4             2
Arm/Group Title Extended Release Naltrexone Placebo Total
Hide Arm/Group Description

One dose of intramuscular injection of 380mg extended-release naltrexone.

Extended release naltrexone

One dose of intramuscular injection of placebo.

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 25 27 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
27
 100.0%
52
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
Female
6
  24.0%
8
  29.6%
14
  26.9%
Male
19
  76.0%
19
  70.4%
38
  73.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
Hispanic or Latino
2
   8.0%
4
  14.8%
6
  11.5%
Not Hispanic or Latino
23
  92.0%
23
  85.2%
46
  88.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 52 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.0%
0
   0.0%
1
   1.9%
White
23
  92.0%
25
  92.6%
48
  92.3%
More than one race
1
   4.0%
0
   0.0%
1
   1.9%
Unknown or Not Reported
0
   0.0%
2
   7.4%
2
   3.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 27 participants 52 participants
25 27 52
1.Primary Outcome
Title Discounting Tasks: Sexual Probability Discounting (SexPD)
Hide Description

In the SexPD task, subjects are asked to choose between having sex with a more appealing partner with a varying chance of having a sexually transmitted infection (STI) or a less appealing partner with no STI.

A hyperbolic decay model was used to calculate h, a free parameter that indexes the rate of probabilistic discounting. Smaller h values indicate a preference for probabilistic (i.e., riskier) outcomes. To normalize the data, the natural log of h values were calculated and reported here.

Time Frame 28 days post drug intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
Participants who were randomized to naltrexone.
Participants who were randomized to receive placebo.
Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: natural log
Baseline_All Number Analyzed 21 participants 25 participants
2.97  (11.07) 6.52  (8.52)
Post_All Number Analyzed 21 participants 25 participants
4.68  (12.07) 7.67  (11.74)
Post_HIV-positive Number Analyzed 6 participants 6 participants
-0.54  (5.16) 1.08  (2.84)
Post_HIV-negative Number Analyzed 15 participants 19 participants
6.55  (13.39) 9.79  (13.38)
2.Primary Outcome
Title Discounting Tasks: Standard Delay Discounting (DD)
Hide Description Monetary delay discounting task consisted of choosing between a larger, delayed and a smaller, immediate reward. A hyperbolic decay model was used to calculate k, a free parameter that indexes the rate of delay discounting. As k values are typically skewed across subjects, the distribution of k was normalized by using a natural log transformation. The normalized values are reported here. If k typically ranges between 0.5 and 10^-5, then the natural log of k will range between -0.69 and -11.5. Larger normalized k values indicate a preference for smaller sooner outcomes (i.e., more impulsive decision-making).
Time Frame 28 days post drug intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
One dose of intramuscular injection of 380mg extended-release naltrexone.
One dose of intramuscular injection of placebo.
Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: natural log
Baseline_All -2.92  (6.06) -3.90  (2.04)
Post_All -2.73  (7.76) -4.25  (1.65)
Post_HIV-positive -5.44  (1.48) -5.56  (1.61)
Post_HIV-negative -1.57  (9.08) -3.88  (1.50)
3.Primary Outcome
Title Barrat Impulsiveness Scale (BIS)
Hide Description The Barrat Impulsiveness Scale (BIS) is a 30 item questionnaire to measure a persons impulsiveness. Items are answered on a 4-point scale and scored 1-4 then summed across responses. Total scores range from 30-120 with a higher summed score indicating higher impulsivity.
Time Frame 28 days post drug intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
Participants randomized to naltrexone.
Participants randomized to placebo.
Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline_All Number Analyzed 21 participants 25 participants
77.5  (14.24) 73.52  (13.16)
Post_All Number Analyzed 21 participants 25 participants
71.79  (10.07) 63.30  (11.53)
Post_HIV-positive Number Analyzed 6 participants 6 participants
70.83  (7.49) 61  (13.15)
Post_HIV-negative Number Analyzed 15 participants 19 participants
72.23  (11.31) 64.47  (11.70)
4.Primary Outcome
Title Risk Assessment Battery (RAB)
Hide Description

The Risk Assessment Battery (RAB) is a 26 question self-administered assessment focusing on drug use, injection and sexual risk during the past 30 days.

Three composite HIV risk scores (drug, sex, and total score) are calculated. The questions have different numbers of items, and scores for a single question can range from 0 to 7, with higher values reflecting more instances of risk behavior. The drug risk score has a range of 0 to 22 and is calculated from 8 questions that address recent substance use, including frequency, needle sharing, and cleaning of the "works." 9 questions are used to calculate a sex risk score that has a range of 0 to 18, and these questions address the frequency and types of sexual behavior, HIV status of sexual partners, and type of protection that was used (if any). Total score is calculated by adding drug and sex scores and dividing by 40, the maximum score possible, and ranges from 0 to 40 where higher scores indicate greater risk behavior.

Time Frame 28 days post drug intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description:
One dose of intramuscular injection of 380mg extended-release naltrexone.
One dose of intramuscular injection of placebo.
Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
DrugRisk_Baseline_All Number Analyzed 21 participants 25 participants
1.33  (2.92) 0.6  (1.87)
DrugRisk_Post_All Number Analyzed 21 participants 25 participants
0.24  (0.54) 0.08  (0.40)
SexRisk_Baseline_All Number Analyzed 21 participants 25 participants
5.48  (3.23) 4.44  (3.16)
SexRisk_Post_All Number Analyzed 21 participants 25 participants
4.81  (2.75) 4.72  (2.89)
TotalRisk_Baseline_All Number Analyzed 21 participants 25 participants
0.17  (0.12) 0.13  (0.09)
TotalRisk_Post_All Number Analyzed 21 participants 25 participants
0.13  (0.07) 0.12  (0.07)
DrugRisk_Baseline_HIV-positive Number Analyzed 6 participants 6 participants
1  (1.67) 0.17  (0.41)
DrugRisk_Post_HIV-positive Number Analyzed 6 participants 6 participants
0  (0) 0  (0)
SexRisk_Baseline_HIV-positive Number Analyzed 6 participants 6 participants
6.5  (4.04) 5.17  (2.64)
SexRisk_Post_HIV-positive Number Analyzed 6 participants 6 participants
5.83  (3.76) 4.17  (1.83)
TotalRisk_Baseline_HIV-positive Number Analyzed 6 participants 6 participants
0.19  (0.08) 0.13  (0.06)
TotalRisk_Post_HIV-positive Number Analyzed 6 participants 6 participants
0.15  (0.094) 0.10  (0.05)
DrugRisk_Baseline_HIV-negative Number Analyzed 15 participants 19 participants
1.47  (3.34) 0.74  (2.13)
DrugRisk_Post_HIV-negative Number Analyzed 15 participants 19 participants
0.33  (0.62) 0.11  (0.46)
SexRisk_Baseline_HIV-negative Number Analyzed 15 participants 19 participants
5.07  (2.91) 4.21  (3.34)
SexRisk_Post_HIV-negative Number Analyzed 15 participants 19 participants
4.4  (2.26) 4.89  (3.18)
TotalRisk_Baseline_HIV-negative Number Analyzed 15 participants 19 participants
0.16  (0.13) 0.12  (0.095)
TotalRisk_Post_HIV-negative Number Analyzed 15 participants 19 participants
0.12  (0.055) 0.13  (0.081)
5.Secondary Outcome
Title Methamphetamine Use
Hide Description Participants were asked "How many days in the past 30 days did you use methamphetamine?". This is a self-report measure.
Time Frame 28 days post drug intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.
Arm/Group Title Extended Release Naltrexone Placebo
Hide Arm/Group Description:

One dose of intramuscular injection of 380mg extended-release naltrexone.

Extended release naltrexone

One dose of intramuscular injection of placebo.

Placebo

Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: days
Post_All 1.33  (3.23) 2.17  (5.52)
Post_HIV-positive 1.17  (1.83) 1.6  (3.58)
Post_HIV-negative 1.4  (3.70) 0.13  (0.52)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Extended Release Naltrexone Placebo
Hide Arm/Group Description

One dose of intramuscular injection of 380mg extended-release naltrexone.

Extended release naltrexone

One dose of intramuscular injection of placebo.

Placebo

All-Cause Mortality
Extended Release Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Extended Release Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Extended Release Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/27 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Todd Korthuis
Organization: Oregon Health & Science University
Phone: 503-494-8044
EMail: korthuis@ohsu.edu
Layout table for additonal information
Responsible Party: P. Todd Korthuis, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01822132     History of Changes
Other Study ID Numbers: ALKIIT-KOR-034
1R21DA033182-01A1 ( U.S. NIH Grant/Contract )
First Submitted: March 21, 2013
First Posted: April 2, 2013
Results First Submitted: September 20, 2017
Results First Posted: February 6, 2019
Last Update Posted: March 5, 2019