Galantamine Effects on Cognitive Function in Marijuana Users

Study Description

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Brief Summary:

To evaluate galantamine's effects on cognitive performance in marijuana users. Galantamine, an acetylcholine esterase inhibitor, is approved for treatment of Alzheimer's disease. Current marijuana users show impaired cognitive functioning, which predicts poor treatment response to behavioral treatments in this population. Whether cognitive impairment in marijuana users will improve with medication treatment has not been evaluated. We hypothesize that galantamine, compared to placebo, will improve cognitive performance in marijuana users.Galantamine, compared to placebo, will improve working memory, verbal learning/memory and response inhibition functions in marijuana users.

Condition or disease	Intervention/treatment	Phase
Memory	Drug: Placebo; Drug: Galantamine	Phase 1

Detailed Description:

To summarize, marijuana users show impaired cognitive functioning, especially in working memory and verbal learning and memory functions. Impaired cognitive functioning predicts poor treatment response in marijuana users. Whether the cognitive impairments in marijuana users improve with cholinergic enhancers has not been evaluated. In this double-blind, parallel-group study, we are proposing to evaluate galantamine's effects on cognitive performance in marijuana users. Thirty subjects will first have an adaptation session to familiarize them with the study procedures including cognitive assessment. The adaptation session will be followed by a 10-day treatment period, in which subjects will be randomized to galantamine (8 mg/day) or placebo. On Day 4 or 5 and Day 9 or10 of each treatment phase subjects will have test sessions, where a battery of cognitive tests will be administered. The cognitive test that will be administered will include the Hopkins Verbal Learning Test (HVLT) modules from the Cambridge Neuropsychological Test Automated Battery (CANTAB): the Rapid Visual Information Processing (RVIP) and the Stop Signal Test (SST).

Currently this study is in data analysis with 30 completers. (April 2011)

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	29 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Screening
Official Title:	Galantamine Effects on Cognitive Function in Marijuana Users
Study Start Date :	August 2009
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	July 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Galatamine; Galantamine is used for the treatment of mild to moderate Alzheimer's disease and various other memory	Drug: Galantamine; 8mg of Galantamine
Placebo Comparator: Sugar Pill; Sugar Pill	Drug: Placebo; 8Mg a day of a sugar pill

Outcome Measures

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Primary Outcome Measures :

1. test whether galantamine in comparison to placebo, will improve cognitive functioning and the effects of galantamine on mood. [ Time Frame: two years ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Men and women between the ages of 18 and 55 who are dependent on or abuse marijuana, according to DSM-IV criteria;
• History of marijuana use on the average of at least twice a week over a one-month period;
• Current marijuana use, indicated by positive urine toxicology for marijuana;
• No current medical problems and normal ECG;
• For women, neither pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

• Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
• Current dependence to other drugs of abuse or alcohol (except nicotine or marijuana dependence);
• History of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
• Use of other medications including a) drugs that slow heart rate (eg, beta-blockers),which may increase the risk of bradycardia and AV block and b) NSAIDs; increased potential for developing ulcers/active or occult gastrointestinal bleeding;
• Known allergy to galantamine

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Connecticut
Department of Veterans Affairs
West Haven, Connecticut, United States, 06516

Sponsors and Collaborators

Yale University

National Institute on Drug Abuse (NIDA)

VA Office of Research and Development

Investigators

Principal Investigator:	Mehmet Sofuoglu, M.D., Ph.D.	Yale University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mehmet Sofuoglu, Principle Investigator, Yale University
ClinicalTrials.gov Identifier:	NCT00969696 History of Changes
Other Study ID Numbers:	0905005104; P50DA009241 ( U.S. NIH Grant/Contract ); MIREC ( Registry Identifier: Veteran's Administration )
First Posted:	September 1, 2009
Last Update Posted:	July 25, 2012
Last Verified:	July 2012

Keywords provided by Mehmet Sofuoglu, Yale University:

ability to learn, working memory

Additional relevant MeSH terms:

Galantamine; 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