Behavioral Effects of Tiagabine and Cannabis
This study is currently recruiting participants.
Verified April 2013 by University of Kentucky
Sponsor:
University of Kentucky
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT01511640
First received: January 9, 2012
Last updated: April 5, 2013
Last verified: April 2013
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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: 26 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | January 2012 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tiagabine 1
Dose 1
|
Drug: Tiagabine
tiagabine or placebo 3x daily for duration of study
|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Tiagabine
tiagabine or placebo 3x 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 three 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
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: | University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT01511640 History of Changes |
| Other Study ID Numbers: | K02-DA031766-01 |
| Study First Received: | January 9, 2012 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Kentucky:
|
marijuana addiction treatment |
pharmacotherapy GABA cannabinoid |
Additional relevant MeSH terms:
|
Tiagabine Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neurotransmitter Uptake Inhibitors |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs GABA Agonists GABA Agents |
ClinicalTrials.gov processed this record on May 16, 2013