Ph1 Marinol Interaction Study - Part 2 - 1

Marijuana Dependence Clinical Trial

Official title:

Phase 1, Pilot Study to Examine the Cardiovascular Effects of Smoked Marijuana, Interactions With Oral Dronabinol, and Effects of Dronabinol on Withdrawal in Marijuana Dependent Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490269
• Other study ID #: NIDA-CPU-0013-1
• Status: Completed
• Phase: Phase 1
• First received: June 21, 2007
• Last updated: January 11, 2017
• Start date: October 2006
• Est. completion date: December 2007

Study information

• Verified date: August 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant drug interactions before conducting outpatient studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Must be between 18 and 45 years of age

• Must be in good general health and who meet DSM-IV diagnostic criteria for marijuana dependence

• Must be seeking treatment at time of study entry

• Must be able to understand and provide written informed consent

• Must provide 1 marijuana positive urine specimen (> 50 ng/mL) within the 28-day screening period

• If female and of child bearing potential, agrees to use birth control.

Exclusion

Criteria:

• Please contact site for more information

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Dependence

Intervention

Drug:
• Placebo

• Dronabinol

Locations

Country	Name	City	State
United States	Uniformed Services University of Health Science	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.	Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.	Day 9 and 10	Yes