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Behavioral Effects of Pregabalin and Cannabis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01511640
Recruitment Status : Recruiting
First Posted : January 18, 2012
Last Update Posted : May 6, 2019
Information provided by (Responsible Party):
Joshua A. Lile, Ph.D., University of Kentucky

Brief Summary:
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 or disease Intervention/treatment Phase
Cannabis-use Disorders Drug: Pregabalin Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Effects of Drugs (Outpatient)(43)
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Pregabalin 1
Dose 1
Drug: Pregabalin
pregabalin 2x daily for duration of study

Placebo Comparator: Placebo 1
Placebo 1
Drug: Placebo
placebo 2x daily for duration of study

Experimental: Pregabalin 2
Dose 2
Drug: Pregabalin
pregabalin 2x daily for duration of study

Placebo Comparator: Placebo 2
Placebo 2
Drug: Placebo
placebo 2x daily for duration of study

Primary Outcome Measures :
  1. number of self-administered puffs of smoked cannabis containing active THC concentrations compared to placebo under controlled laboratory conditions [ Time Frame: 22 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 7-10 days each
  • located in close proximity to University of Kentucky

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01511640

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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.
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Principal Investigator: Joshua A. Lile, Ph.D. University of Kentucky

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Responsible Party: Joshua A. Lile, Ph.D., Associate Professor of Behavioral Science, University of Kentucky Identifier: NCT01511640     History of Changes
Other Study ID Numbers: R01DA036550 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joshua A. Lile, Ph.D., University of Kentucky:
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs