Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

Cocaine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809835
• Other study ID #: 0708002943
• Secondary ID: R01DA015969-13
• Status: Completed
• Phase: Phase 2
• Start date: December 2007
• Est. completion date: January 2015

Study information

• Verified date: January 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Galantamine
Daily 8 mg galantamine capsule

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Kinsella Treatment Center (KTC)	Bridgeport	Connecticut
United States	Regional Network of Programs	Stratford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine Use	Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.	12 weeks
Primary	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	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