Back to resultsBehavioral Effects of Pregabalin and Cannabis
Primary Purpose
Cannabis-use Disorders
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Cannabis-use Disorders focused on measuring marijuana, addiction, treatment, pharmacotherapy, cannabinoid
Eligibility Criteria
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
Sites / Locations
- Laboratory of Human Behavioral Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Pregabalin 1
Placebo 1
Pregabalin 2
Placebo 2
Arm Description
Dose 1
Placebo 1
Dose 2
Placebo 2
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01511640
Brief Title
Behavioral Effects of Pregabalin and Cannabis
Official Title
Behavioral Effects of Drugs (Outpatient)(43)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joshua A. Lile, Ph.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis-use Disorders
Keywords
marijuana, addiction, treatment, pharmacotherapy, cannabinoid
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregabalin 1
Arm Type
Experimental
Arm Description
Dose 1
Arm Title
Placebo 1
Arm Type
Placebo Comparator
Arm Description
Placebo 1
Arm Title
Pregabalin 2
Arm Type
Experimental
Arm Description
Dose 2
Arm Title
Placebo 2
Arm Type
Placebo Comparator
Arm Description
Placebo 2
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
pregabalin 2x daily for duration of study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo 2x daily for duration of study
Primary Outcome Measure Information:
Title
Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions
Description
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.
Time Frame
9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua A. Lile, Ph.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Human Behavioral Pharmacology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0086
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Behavioral Effects of Pregabalin and Cannabis
We'll reach out to this number within 24 hrs