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Behavioral Effects of Tiagabine and Cannabis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
Joshua A. Lile, Ph.D., University of Kentucky
ClinicalTrials.gov Identifier:
NCT01511640
First received: January 9, 2012
Last updated: August 31, 2014
Last verified: August 2014
  Purpose

Cannabis is the most commonly used illicit drug in the United States, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. Currently there is no effective pharmacological treatment for cannabis-use disorders. The purpose of the present study is to evaluate the ability of tiagabine to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.


Condition Intervention Phase
Cannabis-use Disorders
Drug: Tiagabine
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • number of self-administered puffs of smoked cannabis containing active THC concentrations compared to placebo under controlled laboratory conditions [ Time Frame: 24 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: January 2012
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tiagabine 1
Dose 1
Drug: Tiagabine
tiagabine or placebo 2x daily for duration of study
Placebo Comparator: Placebo
Placebo
Drug: Tiagabine
tiagabine or placebo 2x daily for duration of study

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • regular cannabis use
  • good health other than cannabis use
  • willingness to attempt abstinence
  • effective form of birth control in female subjects
  • available for up to 6 hrs every day for two 2-week test periods with an intervening break of 9 days each
  • located in close proximity to University of Kentucky

Exclusion Criteria:

  • contraindication to tiagabine
  • medical screening or history outcomes outside normal ranges or deemed clinical insignificant
  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: NCT01511640

Contacts
Contact: Cleeve Emurian, MS 859-277-3766

Locations
United States, Kentucky
Residential Research Facility Recruiting
Lexington, Kentucky, United States, 40503
Contact: Cleeve Emurian, MS    859-277-3766      
Principal Investigator: Joshua A. Lile, Ph.D.         
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Joshua A. Lile, Ph.D. University of Kentucky
  More Information

Additional Information:
No publications provided

Responsible Party: Joshua A. Lile, Ph.D., Associate Professor of Behavioral Science, University of Kentucky
ClinicalTrials.gov Identifier: NCT01511640     History of Changes
Other Study ID Numbers: R01 DA036550
Study First Received: January 9, 2012
Last Updated: August 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Kentucky:
marijuana
addiction
treatment
pharmacotherapy
GABA
cannabinoid

Additional relevant MeSH terms:
Marijuana Abuse
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Tiagabine
Anticonvulsants
Central Nervous System Agents
GABA Agents
GABA Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014