Trial record 2 of 2 for:
Modafinil | Kampman [Lead]
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 : July 16, 2020
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Sponsor:
Kyle Kampman
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | ModNal | Naltrexone and Placebo | Modafinil and Placebo | Double Placebo |
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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 |
Baseline Characteristics
Arm/Group Title | ModNal | Naltrexone and Placebo | Modafinil and Placebo | Double Placebo | Total | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 45 participants | 40 participants | 37 participants | 42 participants | 164 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
45 100.0%
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40 100.0%
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37 100.0%
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42 100.0%
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164 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 45 participants | 40 participants | 37 participants | 42 participants | 164 participants | |
Female |
15 33.3%
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5 12.5%
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7 18.9%
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14 33.3%
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41 25.0%
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Male |
30 66.7%
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35 87.5%
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30 81.1%
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28 66.7%
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123 75.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 45 participants | 40 participants | 37 participants | 42 participants | 164 participants |
45 | 40 | 37 | 42 | 164 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Kyle Kampman |
Organization: | University of Pennsylvania |
Phone: | 215-222-3200 ext 109 |
EMail: | kampman@mail.med.upenn.edu |
Responsible Party: | Kyle Kampman, University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00142818 |
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: | July 16, 2020 |