Galantamine Effects on Cognitive Function in Marijuana Users

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT00969696

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), US Department of Veterans Affairs (U.S. Fed)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Aug 1, 2009

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

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

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

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mehmet Sofuoglu, Principle Investigator, Yale University

ClinicalTrials.gov Identifier:

NCT00969696

Other Study ID Numbers:

0905005104
P50DA009241
MIREC

First Posted:

Sep 1, 2009

Last Update Posted:

Jul 25, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Mehmet Sofuoglu, Principle Investigator, Yale University

ability to learn, working memory

Additional relevant MeSH terms:

Marijuana Abuse

Galantamine

Study Results

No Results Posted as of Jul 25, 2012