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Galantamine Effects on Cognitive Function in Marijuana Users

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. Identifier: NCT00969696
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : July 25, 2012
National Institute on Drug Abuse (NIDA)
US Department of Veterans Affairs
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University

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)

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana Memory

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

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 ]

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

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

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 identifier (NCT number): NCT00969696

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United States, Connecticut
Department of Veterans Affairs
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
US Department of Veterans Affairs
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Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University

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Responsible Party: Mehmet Sofuoglu, Principle Investigator, Yale University 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    Key Record Dates
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:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents