Clinical trial NCT00809835: Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
Official title: Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Keywords: Cocaine
Methadone
CBT
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-12-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cocaine Use
timeFrame: 12 weeks
measure: Cocaine Abstinence
timeFrame: 12 weeks
Secondary outcomes:
measure: Cognitive Function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Kinsella Treatment Center (KTC)
state: Connecticut
city: Stratford
country: United States
facility: Regional Network of Programs
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen M Carroll, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carroll KM, Nich C, DeVito EE, Shi JM, Sofuoglu M. Galantamine and Computerized Cognitive Behavioral Therapy for Cocaine Dependence: A Randomized Clinical Trial. J Clin Psychiatry. 2018 Jan/Feb;79(1):17m11669. doi: 10.4088/JCP.17m11669.