Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

This study is currently recruiting participants.

Verified by National Institute on Drug Abuse (NIDA), December 2008

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00809835

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 I

Drug Information available for: Methadone Methadone hydrochloride Galantamine hydrobromide Galantamine 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Efficacy Study
Official Title:	Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse With Methadone Maintained Individuals

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Reduction in cocaine use [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	December 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active Galantamine and CBT in addition to methadone	Drug: Galantamine Daily 8 mg galantamine capsule in addition to methadone initially (first week) and 16 mg galantamine capsule as maintenance dose for remaining 7 weeks.
2: Placebo Comparator 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 21 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 8 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: Galina Portnoy, BA

203-386-8802 ext 114

gportnoy@abhct.com

Locations

United States, Connecticut
Reginal Network of Programs	Recruiting
Stratford, Connecticut, United States, 06614

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Kathleen M Carroll, Ph.D.

Yale University

More Information

Responsible Party:	Yale University ( Kathleen Carroll, PhD )
Study ID Numbers:	0708002943, R37 DA 15969
Study First Received:	December 16, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00809835
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Cocaine
Methadone
CBT

Study placed in the following topic categories:

Cocaine-Related Disorders
Galantamine
Disorders of Environmental Origin
Naphazoline
Methadone
Oxymetazoline
Dopamine

Mental Disorders
Phenylephrine
Guaifenesin
Substance-Related Disorders
Phenylpropanolamine
Cocaine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Parasympathomimetics
Respiratory System Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Cholinergic Agents
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Analgesics
Analgesics, Opioid

Nootropic Agents
Central Nervous System Depressants
Enzyme Inhibitors
Narcotics
Cardiovascular Agents
Anesthetics, Local
Pharmacologic Actions
Cholinesterase Inhibitors
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009