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Behavioral Effects of Pregabalin and Cannabis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 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: February 1, 2017
Last verified: February 2017
  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 pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.

Condition Intervention Phase
Cannabis-use Disorders
Drug: Pregabalin
Drug: Placebo
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Behavioral Effects of Drugs (Outpatient)(43)

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: 22 days ]

Estimated Enrollment: 13
Actual Study Start Date: February 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin 1
Dose 1
Drug: Pregabalin
pregabalin 2x daily for duration of study
Placebo Comparator: Placebo
Placebo
Drug: Placebo
placebo 2x daily for duration of study

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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 10 days each
  • located in close proximity to University of Kentucky

Exclusion Criteria:

  • medical screening outcomes outside normal ranges or deemed clinical insignificant
  • medical history that would contraindicate pregabalin administration
  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

Locations
United States, Kentucky
Laboratory of Human Behavioral Pharmacology Recruiting
Lexington, Kentucky, United States, 40536-0086
Contact: Frances Wagner, RN    859-257-5388      
Principal Investigator: Joshua A. Lile, Ph.D.         
Sponsors and Collaborators
Joshua A. Lile, Ph.D.
Investigators
Principal Investigator: Joshua A. Lile, Ph.D. University of Kentucky
  More Information

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: R01DA036550 
Study First Received: January 9, 2012
Last Updated: February 1, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 27, 2017