Behavioral Effects of Pregabalin and Cannabis

• ClinicalTrials.gov Identifier: NCT01511640
• Recruitment Status: Completed
• First Posted: January 18, 2012
• Results First Posted: September 10, 2021
• Last Update Posted: September 10, 2021
• Sponsor: Joshua A. Lile, Ph.D.
• Information provided by (Responsible Party): Joshua A. Lile, Ph.D., University of Kentucky

Tracking Information

• First Submitted Date: January 9, 2012
• First Posted Date: January 18, 2012
• Results First Submitted Date: April 13, 2021
• Results First Posted Date: September 10, 2021
• Last Update Posted Date: September 10, 2021
• Actual Study Start Date: February 1, 2017
• Actual Primary Completion Date: March 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 13, 2021)

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.

• Original Primary Outcome Measures (submitted: January 12, 2012): number of self-administered puffs of smoked cannabis containing active THC concentrations compared to placebo under controlled laboratory conditions [ Time Frame: 38 days ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Behavioral Effects of Pregabalin and Cannabis
• Official Title: Behavioral Effects of Drugs (Outpatient)(43)
• 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 Provided
• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Cannabis-use Disorders

Intervention

• Drug: Pregabalin
  pregabalin 2x daily for duration of study
• Drug: Placebo
  placebo 2x daily for duration of study

Study Arms

• Experimental: Pregabalin 1
  Dose 1
  Intervention: Drug: Pregabalin
• Placebo Comparator: Placebo 1
  Placebo 1
  Intervention: Drug: Placebo
• Experimental: Pregabalin 2
  Dose 2
  Intervention: Drug: Pregabalin
• Placebo Comparator: Placebo 2
  Placebo 2
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 13, 2021): 30
• Original Estimated Enrollment (submitted: January 12, 2012): 12
• Actual Study Completion Date: March 15, 2020
• Actual Primary Completion Date: March 15, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01511640
• Other Study ID Numbers: R01DA036550( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Joshua A. Lile, Ph.D., University of Kentucky
• Original Responsible Party: University of Kentucky
• Current Study Sponsor: Joshua A. Lile, Ph.D.
• Original Study Sponsor: University of Kentucky
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Kentucky
• Verification Date: August 2021