Effects of Dronabinol (Oral THC) on Cannabis Use

Marijuana Smoking Clinical Trial

Official title:

Effects of Dronabinol (Oral THC) on Cannabis Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394185
• Other study ID #: NA_00041251
• Secondary ID: R01DA025044
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 12, 2011
• Last updated: August 2, 2017
• Start date: February 2011
• Est. completion date: September 2012

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Smoking

Intervention

Drug:
• Dronabinol 120mg/day
Participants receive 40mg dronabinol 3 times daily
• Placebo
Participants receive placebo
• Dronabinol 240mg/day
Participants receive 80mg dronabinol 3 times daily

Locations

Country	Name	City	State
United States	Johns Hopkins University (Bayview Campus)	Baltimore	Maryland

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marijuana Self-administration - Progressive Ratio	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	12-day Dronabinol maintenance period
Primary	Marijuana Self-administration - Drug Vs Money Choice	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	12-day Dronabinol maintenance period