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Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

This study is currently recruiting participants.
Verified January 2013 by Yale University
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00809835
First received: December 16, 2008
Last updated: January 28, 2013
Last verified: January 2013
History of Changes

December 16, 2008
January 28, 2013
December 2007
June 2014   (final data collection date for primary outcome measure)
Reduction in cocaine use [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Reduction in cocaine use [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00809835 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cocaine Dependence
  • Drug: Galantamine
    Daily 8 mg galantamine capsule in addition to methadone maintenance.
  • Drug: placebo
    Placebo dose of "galantamine"
  • Experimental: 1
    Active Galantamine and CBT in addition to methadone
    Intervention: Drug: Galantamine
  • Placebo Comparator: 2
    Placebo dose of galantamine in addition to CBT and methadone
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact: Dorothy Eagan, RN, MPH 203-386-8802 dorothy.eagan@yale.edu
Contact: Liz Doohan, BA 203-386-8802 elizabeth.doohan@yale.edu
United States
 
NCT00809835
0708002943, R37 DA 15969
Yes
Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Kathleen M Carroll, Ph.D. Yale University
Yale University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP