Galantamine Effects on Cognitive Function in Marijuana Users
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ClinicalTrials.gov Identifier: NCT00969696 |
Recruitment Status
:
Completed
First Posted
: September 1, 2009
Last Update Posted
: July 25, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Memory | Drug: Placebo Drug: Galantamine | Phase 1 |
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 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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Galatamine
Galantamine is used for the treatment of mild to moderate Alzheimer's disease and various other memory
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Drug: Galantamine
8mg of Galantamine
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Placebo Comparator: Sugar Pill
Sugar Pill
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Drug: Placebo
8Mg a day of a sugar pill
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- test whether galantamine in comparison to placebo, will improve cognitive functioning and the effects of galantamine on mood. [ Time Frame: two years ]

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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

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
United States, Connecticut | |
Department of Veterans Affairs | |
West Haven, Connecticut, United States, 06516 |
Principal Investigator: | Mehmet Sofuoglu, M.D., Ph.D. | Yale University |
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 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:
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 |