Galantamine Effects on Cognitive Function in Marijuana Users

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT00969696
First received: August 31, 2009
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Memory
Drug: Placebo
Drug: Galantamine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Screening
Official Title: Galantamine Effects on Cognitive Function in Marijuana Users

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • test whether galantamine in comparison to placebo, will improve cognitive functioning and the effects of galantamine on mood. [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: August 2009
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969696

Locations
United States, Connecticut
Department of Veterans Affairs
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D., Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Mehmet Sofuoglu, Principle Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00969696     History of Changes
Other Study ID Numbers: 0905005104, P50DA009241, MIREC
Study First Received: August 31, 2009
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Yale University:
ability to learn, working memory

Additional relevant MeSH terms:
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014