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Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence (Mod-Nal)

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ClinicalTrials.gov Identifier: NCT00142818
Recruitment Status : Completed
First Posted : September 2, 2005
Results First Posted : August 29, 2014
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alcohol-Related Disorders
Alcoholism
Cocaine-Related Disorders
Interventions Drug: Naltrexone
Drug: Modafinil
Drug: Placebo
Enrollment 164
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ModNal Naltrexone and Placebo Modafinil and Placebo Double Placebo
Hide Arm/Group Description

Nal + Mod

Naltrexone: 150 mg daily for males; 100 mg daily for females

Modafinil: 400 mg daily

Nal

Naltrexone: 150 mg daily for males; 100 mg daily for females

Mod

Modafinil: 400 mg daily

Placebo

Placebo: 400 mg and/or 100-150 mg placebo pills

Period Title: Overall Study
Started 45 40 37 42
Completed 28 19 24 20
Not Completed 17 21 13 22
Arm/Group Title ModNal Naltrexone and Placebo Modafinil and Placebo Double Placebo Total
Hide Arm/Group Description

Nal + Mod

Naltrexone: 150 mg daily for males; 100 mg daily for females

Modafinil: 400 mg daily

Nal

Naltrexone: 150 mg daily for males; 100 mg daily for females

Mod

Modafinil: 400 mg daily

Placebo

Placebo: 400 mg and/or 100-150 mg placebo pills

Total of all reporting groups
Overall Number of Baseline Participants 45 40 37 42 164
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 40 participants 37 participants 42 participants 164 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
 100.0%
40
 100.0%
37
 100.0%
42
 100.0%
164
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 40 participants 37 participants 42 participants 164 participants
Female
15
  33.3%
5
  12.5%
7
  18.9%
14
  33.3%
41
  25.0%
Male
30
  66.7%
35
  87.5%
30
  81.1%
28
  66.7%
123
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 40 participants 37 participants 42 participants 164 participants
45 40 37 42 164
1.Primary Outcome
Title Cocaine Use (Measured by Timeline Follow Back and Urine Screen at Week 14)
Hide Description [Not Specified]
Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ModNal Naltrexone and Placebo Modafinil and Placebo Double Placebo
Hide Arm/Group Description:

Nal + Mod

Naltrexone: 150 mg daily for males; 100 mg daily for females

Modafinil: 400 mg daily

Nal

Naltrexone: 150 mg daily for males; 100 mg daily for females

Mod

Modafinil: 400 mg daily

Placebo

Placebo: 400 mg and/or 100-150 mg placebo pills

Overall Number of Participants Analyzed 45 40 37 42
Mean (Standard Deviation)
Unit of Measure: number of cocaine negative urine samples
9.3  (8.4) 7.2  (8.1) 10.1  (9.4) 10.5  (9.9)
2.Primary Outcome
Title Number of Days of Abstinence From Drinking and Number of Days of Clinically Significant Drinking (Measured by Timeline Follow Back at Week 14 and the 6-month Evaluation)
Hide Description [Not Specified]
Time Frame 4+13 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Naltrexone-treated Subjects Will Demonstrate a Significantly Greater Reduction in Cocaine Use Measured by the Number of BE-negative Urine Samples and Significantly Reduced Alcohol Use Measured by Fewer Days of Clinically Significant Drinking.
Hide Description [Not Specified]
Time Frame 4+13 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Modafinil-treated Subjects Will Demonstrate a Significantly Greater Reduction in Cocaine Use Measured by the Number of BE-negative Urine Samples and Significantly Reduced Alcohol Use Measured by Fewer Days of Clinically Significant Drinking.
Hide Description [Not Specified]
Time Frame 4+13 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Naltrexone/Modafinil-treated Subjects Will Have Fewer Days of Cocaine Use, More Abstinent Days From Alcohol, and Fewer Heavy Drinking Days During the Follow up Period Compared to Placebo-treated Subjects.
Hide Description [Not Specified]
Time Frame 4+13 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ModNal Naltrexone and Placebo Modafinil and Placebo Double Placebo
Hide Arm/Group Description

Nal + Mod

Naltrexone: 150 mg daily for males; 100 mg daily for females

Modafinil: 400 mg daily

Nal

Naltrexone: 150 mg daily for males; 100 mg daily for females

Mod

Modafinil: 400 mg daily

Placebo

Placebo: 400 mg and/or 100-150 mg placebo pills

All-Cause Mortality
ModNal Naltrexone and Placebo Modafinil and Placebo Double Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ModNal Naltrexone and Placebo Modafinil and Placebo Double Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/45 (24.44%)      6/40 (15.00%)      6/37 (16.22%)      11/42 (26.19%)    
General disorders         
Hospitalization  1  7/45 (15.56%)  9 3/40 (7.50%)  3 3/37 (8.11%)  3 7/42 (16.67%)  11
Exacerbation of cocaine and alcohol  1  4/45 (8.89%)  4 2/40 (5.00%)  2 3/37 (8.11%)  3 6/42 (14.29%)  6
Psychiatric disorders         
Depression or Hallucinations  1  1/45 (2.22%)  1 0/40 (0.00%)  0 0/37 (0.00%)  0 1/42 (2.38%)  1
Social circumstances         
Arrested for Homicide  1  0/45 (0.00%)  0 1/40 (2.50%)  1 0/37 (0.00%)  0 0/42 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ModNal Naltrexone and Placebo Modafinil and Placebo Double Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/45 (24.44%)      10/40 (25.00%)      8/37 (21.62%)      4/42 (9.52%)    
Gastrointestinal disorders         
Nausea  1  11/45 (24.44%)  10/40 (25.00%)  8/37 (21.62%)  4/42 (9.52%) 
Psychiatric disorders         
Anxiety  1  9/45 (20.00%)  2/40 (5.00%)  7/37 (18.92%)  0/42 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Dr. Kyle Kampman
Organization: University of Pennsylvania
Phone: 215-222-3200 ext 109
Responsible Party: Kyle Kampman, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00142818     History of Changes
Other Study ID Numbers: NIDA-12756-3
P50DA012756-03 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Submitted: September 1, 2005
First Posted: September 2, 2005
Results First Submitted: August 12, 2014
Results First Posted: August 29, 2014
Last Update Posted: April 23, 2019