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Completed

NCT Number: NCT00490269

Ph1 Marinol Interaction Study - Part 2 - 1

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.

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Key information

Conditions

Marijuana Dependence Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Uniformed Services University of Health Science

Bethesda, Maryland, 20814 4799, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Placebo

Drug

Other names: Placebo comparator arm

Dronabinol

Drug

Other names: Medication intervention

Primary outcomes

  1. Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.

    Time frame: Day 9 and 10

    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.

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 22, 2007
Registry last updated
Jan 12, 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.

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