Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

NCT ID: NCT00809835

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2015-01-31

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.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard Treatment As Usual (TAU)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

TAU Plus 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.

Group Type: EXPERIMENTAL

Galantamine

Intervention Type: DRUG

Daily 8 mg galantamine capsule

TAU plus 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.

Group Type: EXPERIMENTAL

Computer Assisted Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

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.

TAU plus CBT plus galantamine

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

Group Type: EXPERIMENTAL

Galantamine

Intervention Type: DRUG

Daily 8 mg galantamine capsule

Computer Assisted Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

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.

Interventions

Galantamine

Daily 8 mg galantamine capsule

Intervention Type: DRUG

Computer Assisted Cognitive Behavioral Therapy (CBT)

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen M Carroll, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Kinsella Treatment Center (KTC)

Bridgeport, Connecticut, United States

Regional Network of Programs

Stratford, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29286595 (View on PubMed)

Other Identifiers

R01DA015969-13

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0708002943

Identifier Type: -

Identifier Source: org_study_id