Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

Yale University

Status and phase: Completed; Phase 2

Conditions: Cocaine Dependence

Treatments: Drug: Galantamine; Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00809835

R01DA015969-13 (U.S. NIH Grant/Contract)

0708002943

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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120 participants in 4 patient groups

Standard Treatment As Usual (TAU)

No Intervention group

Description:

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.

TAU Plus Galantamine

Experimental group

Description:

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.

Treatment:

Drug: Galantamine

TAU plus Computer Assisted Cognitive Behavioral Therapy (CBT)

Experimental group

Description:

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.

Treatment:

Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)

TAU plus CBT plus galantamine

Experimental group

Description:

Standard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine.

Treatment:

Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)

Drug: Galantamine