Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

Study Overview
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Brief Summary
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We are testing to see if Galantamine, a learning enhancing medication, will help methadone maintained cocaine abusers with their learning and memory specific to CBT using an innovative CBT computer program.

Detailed Description
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We are proposing a randomized double blind clinical trial of galantamine and our innovative computer-assisted version of CBT, alone and in combination, to improve treatment outcome and cognitive functioning among cocaine users. The proposed study will be the first to evaluate a cognitive enhancing medication as a means of enhancing the effects of an extremely promising empirically validated behavioral therapy for addiction, and hence bridge cognitive neuroscience and behavioral therapies development. The aim is to conduct a 12 week randomized placebo controlled trial, using a 2x2 factorial model, that will evaluate the efficacy of adding computer assisted training in CBT (CBT4CBT) and galantamine to standard treatment for 160 cocaine abusing or dependent methadone-maintained individuals. Participants will be randomized to (1) standard treatment (TAU) plus placebo, (2) TAU plus galantamine, (3) TAU plus CBT4CBT plus placebo, or (4) TAU plus CBT4CBT plus galantamine.

Official Title
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Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: Galantamine
* Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between ages of 18 and 50 Enrolled in RNP methadone program and stable on methadone for at least 3 weeks Current cocaine abuse or dependence according to DSM-IV criteria No current medical problems and normal ECG If female, not currently pregnant or breast feeding and using reliable birth control Fluent in English and have at least a 6th grade reading level Can commit to 12 weeks of treatment and are willing to be randomized Exclusion Criteria: Current major psychiatric illness including mood, psychotic or anxiety disorder History of major medical illnesses including asthma, chronic obstructive lung disease, gastrointestinal ulcer, hepatic or renal impairment, cardiac rhythm disturbances Use of medications including beta blockers and NASAIDs Known allergy to Galantamine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Treatment As Usual (TAU)<br>Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered. | |
| Experimental: TAU Plus Galantamine<br>Standard treatment plus Galantamine. In this study, we will use 8 mg galantamine extended release (ER). Galantamine ER is used once daily. The recommended initial dose is 8 mg/day and the maintenance dose is 16-24 mg/day. | Drug: Galantamine<br>* Daily 8 mg galantamine capsule<br>* Other names: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine;|
| Experimental: TAU plus Computer Assisted Cognitive Behavioral Therapy (CBT)<br>TAU plus computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session. | Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)<br>* CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.<br>|
| Experimental: TAU plus CBT plus galantamine<br>Standard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine. | Drug: Galantamine<br>* Daily 8 mg galantamine capsule<br>* Other names: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine;Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)<br>* CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine Use | Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback. | 12 weeks | 
| Cocaine Abstinence | operationalized by percentage of drug-free urine specimens submitted (We will use the Branan ToxCup Drug Screen Cup onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepine, and opioids) at 12 Weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Function | A composite using a carefully selected neuropsychological battery that includes measures of executive cognitive functioning frequently affected among cocaine users, likely to be important moderators of CBT4CBT, and sensitive to galantamine effects. These will include measures of multiple aspects of attention, cognitive inhibition, sustained attention (CANTAB), decision making (BART), and memory (digit span). Scores ranged from -1.77 to 1.42 with a higher score indicating higher cognitive functioning. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine, Methadone, CBT