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Galantamine Effects on Cognitive Function in Marijuana Users

Primary Purpose

Memory

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo

Galantamine

About this trial

This is an interventional screening trial for Memory focused on measuring ability to learn, working memory

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Veterans Affairs

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Galatamine

Sugar Pill

Arm Description

Galantamine is used for the treatment of mild to moderate Alzheimer's disease and various other memory

Sugar Pill

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00969696

First Posted

August 31, 2009

Last Updated

July 24, 2012

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA), US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT00969696

Brief Title

Galantamine Effects on Cognitive Function in Marijuana Users

Official Title

Galantamine Effects on Cognitive Function in Marijuana Users

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA), US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Memory

Keywords

ability to learn, working memory

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Galatamine

Arm Type

Active Comparator

Arm Description

Galantamine is used for the treatment of mild to moderate Alzheimer's disease and various other memory

Arm Title

Sugar Pill

Arm Type

Placebo Comparator

Arm Description

Sugar Pill

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

8Mg a day of a sugar pill

Intervention Type

Drug

Intervention Name(s)

Galantamine

Intervention Description

8mg of Galantamine

Primary Outcome Measure Information:

Title

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

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mehmet Sofuoglu, M.D., Ph.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Veterans Affairs

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

12. IPD Sharing Statement

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Galantamine Effects on Cognitive Function in Marijuana Users

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