A Placebo-Controlled Double-Blind Combined Treatment of Modafinil and CBT for Cocaine Dependence
NCT ID: NCT00344565
Last Updated: 2012-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2005-11-30
2007-03-31
Brief Summary
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Detailed Description
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Recent findings indicate that cocaine dysregulates reward-related glutamate pathways (Dackis \& O'Brien, 2003; Kalivas et al, 2003). Modafinil is a medication known to improve attention, increase wakefulness, energy, and alertness in part by increasing glutamate levels. In light of this work and the negative affect of cognitive impairments on treatment outcomes, testing cognitive enhancing medications that act on glutamate pathways is a novel promising strategy for improving treatment for cocaine dependence. Modafinil is approved for sleep disorders and is a relatively safe medication for cocaine-dependent participants as it has a low abuse potential and has shown promise in a double blind placebo controlled trial for cocaine dependence (Rush et al, 2002; Jasinski, 2000, Dackis et al, 2005). We therefore propose a double blind placebo controlled 12-week exploratory pilot study of modafinil, a "wakefulness agent," in conjunction with sessions of CBT-RP enhanced with motivational interviewing components.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo, was matched to modafinil up to 400 mg/day. Patients also receive motivational interviewing and Cognitive Behavioral Therapy-Relapse Prevention (CBT-RP)
Modafinil
During the first lead-in week, participants will attend the clinic 3 times per week, participate in one session of neuropsychological assessment and receive motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP). At the end of the first lead-in week participants will be randomized to modafinil or placebo stratified by the levels of cocaine use, and whether or not abstinence was achieved. Participants will then be followed for 11 weeks with measures of cocaine cravings and withdrawal, and drug use outcome, and will receive CBT-RP.
Cognitive Behavioral Therapy--Relapse Prevention
Once weekly individual session of motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP)
Modafinil
Modafinil (Active comparator). Patients received motivational interviewing and Cognitive Behavioral Therapy--relapse prevention (CBT-RP)
Modafinil
During the first lead-in week, participants will attend the clinic 3 times per week, participate in one session of neuropsychological assessment and receive motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP). At the end of the first lead-in week participants will be randomized to modafinil or placebo stratified by the levels of cocaine use, and whether or not abstinence was achieved. Participants will then be followed for 11 weeks with measures of cocaine cravings and withdrawal, and drug use outcome, and will receive CBT-RP.
Cognitive Behavioral Therapy--Relapse Prevention
Once weekly individual session of motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP)
Interventions
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Modafinil
During the first lead-in week, participants will attend the clinic 3 times per week, participate in one session of neuropsychological assessment and receive motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP). At the end of the first lead-in week participants will be randomized to modafinil or placebo stratified by the levels of cocaine use, and whether or not abstinence was achieved. Participants will then be followed for 11 weeks with measures of cocaine cravings and withdrawal, and drug use outcome, and will receive CBT-RP.
Cognitive Behavioral Therapy--Relapse Prevention
Once weekly individual session of motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Used cocaine at least eight days in the past month or reports episodic binges of large amounts of cocaine (at least $150 worth) at least twice per month
* Able to give informed consent and comply with study procedures.
Exclusion Criteria
* Baseline 21 item Hamilton Depression Scale scores ≥ 15
* History of seizures
* Chronic organic mental disorder.
* Significant current suicidal risk.
* Pregnancy, lactation, or failure in sexually active female participants to use adequate contraceptive methods.
* Unstable physical disorders, which might make participation hazardous such as hypertension, hepatitis, participants with mildly elevated AST and ALT levels (\< 3 X upper limit or normal are acceptable), or diabetes.
* Coronary vascular disease as indicated by history, or suspected by abnormal EKG or history of cardiac symptoms.
* Current use of prescribed psychotropic medications.
* Current use of medications that interact with modafinil: Tricyclic anti-depressants; MOA Inhibitors; diazepam; phenytoin and medications containing Ethinyl Estradiol
* Known hypersensitivity to modafinil
* Currently meets DSM-IV criteria for narcolepsy
* Currently meets DSM-IV criteria for ADHD
* Currently meets DSM-IV criteria for opioid or sedative-hypnotic dependence.
* Currently meets criteria for DSM-IV alcohol dependence with evidence of clinically significant physiological dependence in need of medically supervised detoxification.
* Current cannabis dependence is identified as the main problem-i.e. participants with current DSM-IV cannabis dependence are eligible, as long as cocaine is identified by the participant as the primary substance problem for which they are seeking treatment.
* Gross visual or auditory impairments
* First language is not English and received NO formal education in English-speaking school
18 Years
55 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Research Foundation for Mental Hygiene, Inc.
OTHER
Responsible Party
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Efrat Aharonovich
Research Scientist
Principal Investigators
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Efrat Aharonovich, PhD
Role: PRINCIPAL_INVESTIGATOR
Columbia University - New York State Psychiatric Institute
Countries
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Other Identifiers
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# 5148
Identifier Type: -
Identifier Source: org_study_id