Skip to main content
OpenTrials
Completed

NCT Number: NCT00893074

The Effect of Prescription Medications in Marijuana Users

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Marijuana Abuse Behavior Chemically-Induced Disorders Marijuana Use Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dronabinol 30mg/day

Drug

10mg dronabinol administered 3x/day for 5 days

Other names: THC, Marinol

Dronabinol 60mg/day

Drug

20mg dronabinol administered 3x/day for 5 days

Other names: THC, Marinol

Dronabinol 120mg/day

Drug

40mg dronabinol administered 3x/day for 5 days

Other names: THC, Marinol

Placebo

Drug

placebo dronabinol administered 3x/day for 5 days

Primary outcomes

  1. Peak Effect of Marijuana Withdrawal

    Time frame: Day 5 of the Dronabinol abstinence period

    Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).

  2. Subjective "Drug Effect" After Smoked Marijuana

    Time frame: Day 5 of the Dronabinol abstinence period

    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

Secondary outcomes

  1. Heart Rate

    Time frame: Assessed on Day 5 of dronabinol maintenance

    Heart rate measured after acute cannabis exposure

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 5, 2009
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.