Behavioral Effects of Pregabalin and Cannabis

NCT01511640 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: R01DA036550
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis-use Disorders

Keywords

marijuana; addiction; treatment; pharmacotherapy; cannabinoid

Outcome Measures

Primary Outcomes (1)

• Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions

  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.

Study Arms (4)

Pregabalin 1

EXPERIMENTAL

Dose 1

Drug: Pregabalin

Placebo 1

PLACEBO COMPARATOR

Placebo 1

Drug: Placebo

Pregabalin 2

EXPERIMENTAL

Dose 2

Drug: Pregabalin

Placebo 2

PLACEBO COMPARATOR

Placebo 2

Drug: Placebo

Interventions

Pregabalin DRUG

pregabalin 2x daily for duration of study

Pregabalin 1; Pregabalin 2

Placebo DRUG

placebo 2x daily for duration of study

Placebo 1; Placebo 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Joshua A. Lile, Ph.D.: lead

Study Sites (1)

Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, 40536-0086, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Behavior, Addictive

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Joshua Lile, Ph.D., Professor
• Organization: University of Kentucky College of Medicine

jalile2@uky.edu

8593236034

Study Officials

• Joshua A. Lile, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Behavioral Science

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 18, 2012
• Study Start: February 1, 2017
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: September 10, 2021
• Results First Posted: September 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)