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Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

This study has been completed.
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: May 11, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Cocaine Dependence Drug: Galantamine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals

Resource links provided by NLM:


Further study details as provided by Yale University:

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

  • 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:
  • 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.



Enrollment: 120
Study Start Date: December 2007
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809835

Locations
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
Principal Investigator: Kathleen M Carroll, Ph.D. Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00809835     History of Changes
Other Study ID Numbers: 0708002943
R01DA015969-13 ( US NIH Grant/Contract Award Number )
Study First Received: December 16, 2008
Results First Received: August 4, 2016
Last Updated: May 11, 2017
Individual Participant Data  
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:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Galantamine
Cocaine
Methadone
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
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Antitussive Agents
Respiratory System Agents
Anesthetics, Local
Anesthetics
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators

ClinicalTrials.gov processed this record on June 23, 2017