Behavioral Effects of Pregabalin and Cannabis

Early Phase 1

Completed

• Conditions: Cannabis-use Disorders
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT01511640
• Lead Sponsor: Joshua A. Lile, Ph.D.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-18
• Study Start: 2017-02-01
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Results First Submitted: 2021-04-13
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-13
• Last Update Submitted: 2021-08-13
• Results First Posted: 2021-09-10
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo 2	Placebo	Placebo 2
Placebo 1	Placebo	Placebo 1
Pregabalin 2	Pregabalin	Dose 2
Pregabalin 1	Pregabalin	Dose 1

Primary Outcome Measures

Name	Time	Method
Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions	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.

Trial Locations

Locations (1)

Laboratory of Human Behavioral Pharmacology; 🇺🇸 Lexington, Kentucky, United States