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Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00809835
First received: December 16, 2008
Last updated: October 3, 2014
Last verified: October 2014

December 16, 2008
October 3, 2014
December 2007
January 2015   (final data collection date for primary outcome measure)
  • Cocaine use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Reduction in cocaine use, operationalized as the frequency of cocaine use by week using the Substance Use Calendar
  • Cocaine Abstinence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Operationalized by number 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.
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
Cognitive Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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, memory, and inhibitory control (CANTAB) cognitive inhibition (classic Stroop), sustained attention (CPT), decision making (EDT, MIDT and BART), and attentional bias (cocaine Stroop).
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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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cocaine Dependence
  • Drug: Galantamine
    Daily 8 mg galantamine capsule
    Other Name: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
  • 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.
  • No Intervention: 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.
  • Experimental: 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.
    Intervention: Drug: Galantamine
  • Experimental: 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.
    Intervention: Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)
  • Experimental: TAU plus CBT plus galantamine
    Standard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine.
    Interventions:
    • Drug: Galantamine
    • Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
January 2015
January 2015   (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 information is only displayed when the study is recruiting subjects
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
October 2014

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