The Effect of Prescription Medications in Marijuana Users

Marijuana Abuse Clinical Trial

Official title:

The Effect of Prescription Medications in Marijuana Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893074
• Other study ID #: NA_00026278
• Secondary ID: R01DA025044
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 30, 2009
• Last updated: August 2, 2017
• Start date: April 2009
• Est. completion date: October 2011

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A subset of heavy marijuana users have trouble quitting marijuana use and the number of those seeking treatment for problems related to marijuana is increasing. The purpose of this research study is to investigate whether dronabinol can reduce withdrawal effects associated with stopping marijuana use, if dronabinol can reduce the rewarding effects of smoked marijuana, and whether there are any cognitive performance deficits associated with dronabinol doses that produce such effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• current use of marijuana

• able to give informed consent

Exclusion Criteria:

• dependence on drug other than marijuana

• pregnant, breast feeding, or planning to become pregnant within the next 3 months

• currently seeking treatment for cannabis-related problems or otherwise trying to reduce use

• use of cannabis under the guidance of a physician for a medical disorder

• unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina)

• allergy to study medication

Related Conditions & MeSH terms

• Marijuana Abuse

Intervention

Drug:
• Dronabinol 30mg/day
10mg dronabinol administered 3x/day for 5 days
• Dronabinol 60mg/day
20mg dronabinol administered 3x/day for 5 days
• Dronabinol 120mg/day
40mg dronabinol administered 3x/day for 5 days
• Placebo
placebo dronabinol administered 3x/day for 5 days

Locations

Country	Name	City	State
United States	Behavioral Pharmacology Research Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vandrey R, Stitzer ML, Mintzer MZ, Huestis MA, Murray JA, Lee D. The dose effects of short-term dronabinol (oral THC) maintenance in daily cannabis users. Drug Alcohol Depend. 2013 Feb 1;128(1-2):64-70. doi: 10.1016/j.drugalcdep.2012.08.001. Epub 2012 Aug — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Effect of Marijuana Withdrawal	Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).	Day 5 of the Dronabinol abstinence period
Primary	Subjective "Drug Effect" After Smoked Marijuana	Subjective drug effects on a 100mm point Visual Analog Scale reported following acute cannabis dose administration during dronabinol maintenance, scale ranging 0-100, with 0 being no effect and 100 being maximum effect	Day 5 of the Dronabinol abstinence period
Secondary	Heart Rate	Heart rate measured after acute cannabis exposure	Assessed on Day 5 of dronabinol maintenance