Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
2 other identifiers
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2007
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 16, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
June 12, 2017
CompletedJanuary 30, 2019
January 1, 2019
7.1 years
December 16, 2008
August 4, 2016
January 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cocaine Use
Reduction in cocaine use, operationalized as the frequency of cocaine use by month using timeline followback.
12 weeks
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 Outcomes (1)
Cognitive Function
12 weeks
Study Arms (4)
Standard Treatment As Usual (TAU)
NO INTERVENTIONStandard 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.
TAU Plus Galantamine
EXPERIMENTALStandard 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.
TAU plus Computer Assisted Cognitive Behavioral Therapy (CBT)
EXPERIMENTALTAU 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.
TAU plus CBT plus galantamine
EXPERIMENTALStandard treatment, plus computer assisted cognitive behavioral therapy, plus galantamine.
Interventions
Daily 8 mg galantamine capsule
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
Kinsella Treatment Center (KTC)
Bridgeport, Connecticut, 06604, United States
Regional Network of Programs
Stratford, Connecticut, 06615, United States
Related Publications (1)
Carroll KM, Nich C, DeVito EE, Shi JM, Sofuoglu M. Galantamine and Computerized Cognitive Behavioral Therapy for Cocaine Dependence: A Randomized Clinical Trial. J Clin Psychiatry. 2018 Jan/Feb;79(1):17m11669. doi: 10.4088/JCP.17m11669.
PMID: 29286595DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kathleen M. Carroll, Ph.D., Albert E Kent Professor of Psychiatry
- Organization
- Yale University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen M Carroll, Ph.D.
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2008
First Posted
December 17, 2008
Study Start
December 1, 2007
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
January 30, 2019
Results First Posted
June 12, 2017
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share
De-identified data will be available to other researchers upon request. Please contact Dr. Carroll