Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse
This study is currently recruiting participants.
Verified January 2013 by Yale University
Sponsor:
Yale University
Collaborator:
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
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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 Drug: placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals |
Resource links provided by NLM:
Drug Information available for:
Cocaine hydrochloride
Methadone
Galantamine
Methadone hydrochloride
Galantamine hydrobromide
U.S. FDA Resources
Further study details as provided by Yale University:
Primary Outcome Measures:
- Reduction in cocaine use [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 160 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Active Galantamine and CBT in addition to methadone
|
Drug: Galantamine
Daily 8 mg galantamine capsule in addition to methadone maintenance.
|
|
Placebo Comparator: 2
Placebo dose of galantamine in addition to CBT and methadone
|
Drug: placebo
Placebo dose of "galantamine"
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809835
Contacts
| Contact: Dorothy Eagan, RN, MPH | 203-386-8802 | dorothy.eagan@yale.edu |
| Contact: Liz Doohan, BA | 203-386-8802 | elizabeth.doohan@yale.edu |
Locations
| United States, Connecticut | |
| Kinsella Treatment Center (KTC) | Recruiting |
| Bridgeport, Connecticut, United States, 06604 | |
| Contact: Elizabeth Doohan, BA 203-335-2173 elizabeth.doohan@yale.edu | |
| Contact: Alexa Pazniokas, BA 203-335-2173 alexa.pazniokas@yale.edu | |
| Regional Network of Programs | Recruiting |
| Stratford, Connecticut, United States, 06615 | |
| Contact: Dorothy Eagan, RN, MPH 203-386-8802 ext 157 dorothy.eagan@yale.edu | |
| Contact: Liz Doohan, BA 203-386-8802 ext 155 elizabeth.doohan@yale.edu | |
| Principal Investigator: Kathleen Carroll, PhD | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Kathleen M Carroll, Ph.D. | Yale University |
More Information
No publications provided
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00809835 History of Changes |
| Other Study ID Numbers: | 0708002943, R37 DA 15969 |
| Study First Received: | December 16, 2008 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Yale University:
|
Cocaine Methadone CBT |
Additional relevant MeSH terms:
|
Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Cocaine Galantamine Methadone Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors |
Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Parasympathomimetics Autonomic Agents Nootropic Agents Cholinesterase Inhibitors Enzyme Inhibitors Cholinergic Agents Analgesics, Opioid Analgesics |
ClinicalTrials.gov processed this record on May 21, 2013