Ph1 Marinol Interaction Study - Part 1 - 1

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00438139

Enrollment

Registered

2007-02-21

Start date

2007-03-31

Completion date

2007-03-31

Last updated

2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marijuana Dependence

Keywords

marijuana dependence

Brief summary

The purpose of this study is to 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 interactions before conducting outpatient studies.

Interventions

DRUGDronabinol

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Must be between the ages of 18 to 45 years of age * Must be in good general health * Must meet DSM-IV criteria for marijuana dependence and are non- treatment seekers at the time of study * Must be able to provide written informed consent * Must be able to provide 1 marijuana positive urine specimen (\> 50 ng/mL) within the 28-day screening period * If female and of child bearing potential, must agree to use birth control. Exclusion Criteria: * Please contact site for more information.

Design outcomes

Primary

Measure	Time frame
Cardiovascular responses	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026