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Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00809835
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : June 12, 2017
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Galantamine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals
Study Start Date : December 2007
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Galantamine
Daily 8 mg galantamine capsule
Other Name: Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine
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.
 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.
Experimental: TAU plus CBT plus galantamine
Standard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Cocaine Use [ Time Frame: 12 weeks ]
    Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.

  2. Cocaine Abstinence [ Time Frame: 12 weeks ]
    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


Secondary Outcome Measures :
  1. Cognitive Function [ Time Frame: 12 weeks ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809835


Locations
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United States, Connecticut
Kinsella Treatment Center (KTC)
Bridgeport, Connecticut, United States, 06604
Regional Network of Programs
Stratford, Connecticut, United States, 06615
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kathleen M Carroll, Ph.D. Yale University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00809835    
Other Study ID Numbers: 0708002943
R01DA015969-13 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2008    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be available to other researchers upon request. Please contact Dr. Carroll
Keywords provided by Yale University:
Cocaine
Methadone
CBT
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents