Behavioral Effects of Pregabalin and Cannabis

August 13, 2021 updated by: Joshua A. Lile, Ph.D.

Behavioral Effects of Drugs (Outpatient)(43)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0086
        • Laboratory of Human Behavioral Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregabalin 1
Dose 1
Drug: Pregabalin
pregabalin 2x daily for duration of study
Placebo Comparator: 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
Drug: Placebo
placebo 2x daily for duration of study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions
Time Frame: 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level.
The reinforcing effects of cannabis were determined using a modified progressive ratio procedure in which subjects made 8 choices between puffs of each available cannabis dose and money (US$0.50). The numbered of self-administered puffs of smoked cannabis are measured for each cannabis concentration (0 and 5.9% THC) during active (300 and 450 mg) and placebo (0 mg and 0 mg) pregabalin maintenance.
9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joshua A. Lile, Ph.D.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

March 15, 2020

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 12, 2012

First Posted (Estimate)

January 18, 2012

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA036550 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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