Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kathleen M. Carroll, Yale University
ClinicalTrials.gov Identifier:
NCT00809835
First received: December 16, 2008
Last updated: May 15, 2014
Last verified: May 2014
  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:


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

No publications provided

Responsible Party: Kathleen M. Carroll, Professor, 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: May 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Cocaine
Methadone
CBT

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Galantamine
Methadone
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Parasympathomimetics
Autonomic Agents
Nootropic Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on August 28, 2014