Cocaine Dependence
Conditions
Keywords
Cocaine Dependence
Brief summary
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.
Detailed description
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.
Interventions
DRUGModafinil
200mg Modafinil
DRUGMatching Placebo
Matching Placebo
Sponsors
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Seeking treatment for cocaine dependence * Meets DSM-IV diagnosis criteria for cocaine dependence as determined by Mini-SCID interview * If female, willing to use effective contraception throughout the study * Lives within 50 miles of the research center and has reliable transportation
Exclusion criteria
* Meets DSM-IV/Mini-SCID diagnosis criteria for dependence on any drugs other than cocaine, alcohol, nicotine, or marijuana * Physiologic dependence on alcohol requiring medical detoxification, on either an inpatient or outpatient basis * Current psychiatric disorder, including depression, schizophrenia, bipolar affective disorder, organic brain disease, dementia, or other types of psychosis * Recent suicidal or homicidal attempts within 60 days of study entry * Suicidal or homicidal ideation within 30 days of study entry * Meets diagnosis criteria from the Differential Diagnosis of Psychotic Disorders section of Mini-SCID for a history of psychotic symptoms during a period of cocaine use (e.g., persistent hallucinations and delusions) * Serious medical illness, including left ventricular hypertrophy, mitral valve prolapse, left bundle branch block, heart attack, angina, serious liver disease (transaminase levels four times greater than normal), and kidney, neurologic, metabolic, neoplastic, nutritional, inflammatory, or endocrine disorders * Required by the court to obtain treatment for cocaine dependence * Not seeking treatment for cocaine dependence * Participated in cocaine treatment (clinical or research) within 30 days of study entry * Anticipating elective surgery or hospitalization within 20 weeks of study entry * Known or suspected hypersensitivity to modafinil * Use of any of the following medications within 14 days of study entry: selective serotonin reuptake inhibitor antidepressants, tricyclic antidepressants, dopamine agonists, and other psychotropic medications, including anticonvulsants, antipsychotics, anxiolytics, or psychostimulants * Currently taking medications that could adversely interact with study medications, including azole-type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine * Currently taking any medications that induce or inhibit CYP3A4 metabolic pathways * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cocaine Non-use Days | 8 weeks | Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels. |
| Percent of Participants With New Use | 8 weeks | New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 200mg Modafinil 200mg Modafinil
Modafinil: 200mg Modafinil | 40 |
| 400mg Modafinil 400mg Modafinil
Modafinil: 400mg Modafinil | 43 |
| Matching Placebo Matching Placebo
Matching Placebo: Matching Placebo | 40 |
| Total | 123 |
Baseline characteristics
| Characteristic | 200mg Modafinil | 400mg Modafinil | Matching Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 39.0 years STANDARD_DEVIATION 7.1 | 40.4 years STANDARD_DEVIATION 7.2 | 40.0 years STANDARD_DEVIATION 8.8 | 39.8 years STANDARD_DEVIATION 7.2 |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 9 Participants | 29 Participants |
| Sex: Female, Male Male | 30 Participants | 33 Participants | 31 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 33 / 40 | 34 / 43 | 27 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 43 | 0 / 40 |
Outcome results
Primary
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
Population: The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 200mg Modafinil | Number of Cocaine Non-use Days | No Alcohol Dependence | 10.1 Number of Days | Standard Error 2.4 |
| 200mg Modafinil | Number of Cocaine Non-use Days | Alcohol Dependence | 14.1 Number of Days | Standard Error 2.5 |
| 400mg Modafinil | Number of Cocaine Non-use Days | No Alcohol Dependence | 17.1 Number of Days | Standard Error 2.3 |
| 400mg Modafinil | Number of Cocaine Non-use Days | Alcohol Dependence | 9.4 Number of Days | Standard Error 2.5 |
| Matching Placebo | Number of Cocaine Non-use Days | No Alcohol Dependence | 9.3 Number of Days | Standard Error 2.7 |
| Matching Placebo | Number of Cocaine Non-use Days | Alcohol Dependence | 12.8 Number of Days | Standard Error 2.4 |
Primary
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
Population: The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 200mg Modafinil | Percent of Participants With New Use | No Alcohol Dependence | 54.2 Percentage of participants |
| 200mg Modafinil | Percent of Participants With New Use | Alcohol Dependence | 39.7 Percentage of participants |
| 400mg Modafinil | Percent of Participants With New Use | No Alcohol Dependence | 42.0 Percentage of participants |
| 400mg Modafinil | Percent of Participants With New Use | Alcohol Dependence | 42.0 Percentage of participants |
| Matching Placebo | Percent of Participants With New Use | No Alcohol Dependence | 55.8 Percentage of participants |
| Matching Placebo | Percent of Participants With New Use | Alcohol Dependence | 49.0 Percentage of participants |