Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

Phase 2

Completed

Interventions: Drug: Galantamine
Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
TAU Plus Galantamine	Galantamine	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.
TAU plus Computer Assisted Cognitive Behavioral Therapy (CBT)	Computer Assisted Cognitive Behavioral Therapy (CBT)	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.
TAU plus CBT plus galantamine	Galantamine	Standard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine.
TAU plus CBT plus galantamine	Computer Assisted Cognitive Behavioral Therapy (CBT)	Standard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine.

Primary Outcome Measures

Name	Time	Method
Cocaine Use	12 weeks	Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.
Cocaine Abstinence	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Cognitive Function	12 weeks	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.

Locations (2): Regional Network of Programs
🇺🇸
Stratford, Connecticut, United States
Kinsella Treatment Center (KTC)
🇺🇸
Bridgeport, Connecticut, United States