A Phase 2 interventional study of Modafinil and Modafinil in Cocaine Dependence, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-10.
Sponsored by Medical University of South Carolina · Phase 2, Interventional, and Treatment
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may be useful in preventing relapse among individuals with cocaine addiction. This study will evaluate the effectiveness of modafinil, in combination with cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.
The development of a medication to treat cocaine addiction specifically by lessening withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms include depression, lack of energy, and poor concentration. Modafinil, a central nervous system stimulant, is a medication that can speed up physical and mental processes in the brain. It is currently used to treat narcolepsy, a condition that causes excessive sleepiness. Modafinil enhances mood, increases energy, and improves concentration in people with narcolepsy. Modafinil may also cause the same effects in individuals addicted to cocaine, thereby countering the symptoms of cocaine withdrawal. The purpose of this study is to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating cocaine dependence.
A 2-week screening period will be followed by an 8-week treatment phase. Participants will be randomly assigned to receive either 200 mg of modafinil, 400 mg of modafinil, or placebo on a daily basis for the 8 weeks of treatment. During this time, participants will be asked to report the number of days that they use and do not use cocaine. This will be confirmed three times a week with urine tests. Mood, level of daytime sleepiness, and symptoms of cocaine withdrawal and cocaine "high" will be evaluated. Compliance with study medication will be assessed with urine and blood tests. Medication side effects will be monitored through physical examinations, routine lab tests, ECGs, and self-reports. Follow-up evaluations will occur 4 and 8 weeks following the end of treatment.
419 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's enrollment of 123 is above the median of 60 across 315 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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Exclusion criteria:
200mg Modafinil
Drug: Modafinil
400mg Modafinil
Drug: Modafinil
Matching Placebo
Drug: Matching Placebo
Number of Cocaine Non-use Days
Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.
Time frame: 8 weeks
Percent of Participants With New Use
New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.
Time frame: 8 weeks
| Milestone | 200mg Modafinil | 400mg Modafinil | Matching Placebo |
|---|---|---|---|
| Started | 40 | 43 | 40 |
| Completed | 25 | 25 | 17 |
| Not completed | 15 | 18 | 23 |
Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.
| Number of Days | 200mg Modafinil | 400mg Modafinil | Matching Placebo |
|---|---|---|---|
| No Alcohol Dependence | 10.1 ± 2.4 | 17.1 ± 2.3 | 9.3 ± 2.7 |
| Alcohol Dependence | 14.1 ± 2.5 | 9.4 ± 2.5 | 12.8 ± 2.4 |
New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.
| Percentage of participants | 200mg Modafinil | 400mg Modafinil | Matching Placebo |
|---|---|---|---|
| No Alcohol Dependence | 54.2 | 42.0 | 55.8 |
| Alcohol Dependence | 39.7 | 42.0 | 49.0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 200mg Modafinil | — | 0/40 (0%) | 33/40 (82.5%) |
| 400mg Modafinil | — | 0/43 (0%) | 34/43 (79.1%) |
| Matching Placebo | — | 0/40 (0%) | 27/40 (67.5%) |
| Event | 200mg Modafinil | 400mg Modafinil | Matching Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 13/40 | 16/43 | 10/40 |
| InsomniaPsychiatric disorders | 7/40 | 12/43 | 3/40 |
| NauseaGastrointestinal disorders | 5/40 | 8/43 | 5/40 |
| SleepinessPsychiatric disorders | 1/40 | 2/43 | 6/40 |
| Heart RacingCardiac disorders | 5/40 | 5/43 | 1/40 |
| Muscle AcheMusculoskeletal and connective tissue disorders | 4/40 | 1/43 | 1/40 |
| Rapid Heart RateCardiac disorders | 3/40 | 3/43 | 0/40 |
| HeartburnGastrointestinal disorders | 1/40 | 2/43 | 3/40 |
| Dry MouthGastrointestinal disorders | 1/40 | 3/43 | 0/40 |
| IrritabilityPsychiatric disorders | 0/40 | 0/43 | 2/40 |
| Age, Continuous(years) | 200mg Modafinil | 400mg Modafinil | Matching Placebo | Total |
|---|---|---|---|---|
| Mean | 39.0 ± 7.1 | 40.4 ± 7.2 | 40.0 ± 8.8 | 39.8 ± 7.2 |
| Sex: Female, Male(Participants) | 200mg Modafinil | 400mg Modafinil | Matching Placebo | Total |
|---|---|---|---|---|
| Female | 10 | 10 | 9 | 29 |
| Male | 30 | 33 | 31 | 94 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Modafinil
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