Galantamine Effects on Cognitive Function in Marijuana Users

NCT00969696 | Completed Phase 1 DMC

• 3 other identifiers: 0905005104P50DA009241MIREC
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory

Keywords

ability to learn, working memory

Outcome Measures

Primary Outcomes (1)

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

  two years

Study Arms (2)

Galatamine

ACTIVE COMPARATOR

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

Drug: Galantamine

Sugar Pill

PLACEBO COMPARATOR

Sugar Pill

Drug: Placebo

Interventions

Placebo DRUG

8Mg a day of a sugar pill

Sugar Pill

Galantamine DRUG

8mg of Galantamine

Galatamine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Department of Veterans Affairs

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Interventions

Galantamine

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mehmet Sofuoglu, M.D., Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

US (1)