Skip to main content
OpenTrials
Completed

NCT Number: NCT01394185

Effects of Dronabinol (Oral THC) on Cannabis Use

Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days in a randomized order. During each dronabinol maintenance period they were able to self-administer active or placebo cannabis using either a progressive ratio schedule or choice between cannabis and monetary alternative.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Marijuana Smoking Behavior Chemically-Induced Disorders Marijuana Abuse Marijuana Use Mental Disorders Smoking Smoking, Non-Tobacco Products Substance-Related Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Johns Hopkins University (Bayview Campus)

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

  • Daily use of psychoactive medication
  • Current Axis I psychiatric disorder other than dependence on cannabis or nicotine, or abuse of drugs or alcohol
  • Women who are pregnant, breast feeding, or planning to become pregnant within the next 3 months
  • Those seeking treatment for cannabis-related problems or using cannabis under the guidance of a physician for a medical disorder
  • Uncontrolled or unstable cardiovascular disease
  • Allergy to sesame oil

Treatment and study plan

Dronabinol 120mg/day

Drug

Participants receive 40mg dronabinol 3 times daily

Other names: Marinol, THC

Placebo

Drug

Participants receive placebo

Dronabinol 240mg/day

Drug

Participants receive 80mg dronabinol 3 times daily

Other names: Marinol, THC

Primary outcomes

  1. Marijuana Self-administration - Progressive Ratio

    Time frame: 12-day Dronabinol maintenance period

    Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint

  2. Marijuana Self-administration - Drug Vs Money Choice

    Time frame: 12-day Dronabinol maintenance period

    Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 14, 2011
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.