Behavioral Effects of Pregabalin and Cannabis

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.

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Key information

Conditions

Cannabis-use Disorders Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Impulsive Behavior Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, 40536-0086, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

pregabalin 2x daily for duration of study

Placebo

Drug

placebo 2x daily for duration of study

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Joshua A. Lile, Ph.D.

Other

Registry information

Official study title

Behavioral Effects of Drugs (Outpatient)(43)

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Jan 18, 2012
Registry last updated: Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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