Galantamine Effects on Cognitive Function in Marijuana Users

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00969696

First Posted: September 1, 2009

Last Update Posted: July 25, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

National Institute on Drug Abuse (NIDA)

VA Office of Research and Development

Information provided by (Responsible Party):

Mehmet Sofuoglu, Yale University

Purpose

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	Intervention	Phase
Memory	Drug: Placebo Drug: Galantamine	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Screening
Official Title:	Galantamine Effects on Cognitive Function in Marijuana Users

Resource links provided by NLM:

MedlinePlus related topics: Marijuana Memory

Drug Information available for: Galantamine Galantamine hydrobromide

U.S. FDA Resources

Further study details as provided by Mehmet Sofuoglu, Yale University:

Primary Outcome Measures:

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


Enrollment:	29
Study Start Date:	August 2009
Study Completion Date:	July 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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)

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969696

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


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 Submitted:	August 31, 2009
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

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