NCT00218504

Brief Summary

The majority of past research on marijuana treatment has targeted the alleviation of withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a role in treating marijuana addiction. Treatment with tetrahydrocannabinol (THC), the main ingredient in marijuana responsible for its reinforcing effects, may decrease marijuana cravings. The purpose of this study is to evaluate the effect of THC pre-treatment on responses to marijuana-related cues versus non marijuana-related cues in individuals addicted to marijuana.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

First QC Date

September 16, 2005

Last Update Submit

June 1, 2012

Conditions

Marijuana Abuse

Outcome Measures

Primary Outcomes (1)

  • Marijuana craving

    Measured throughout the cue exposure session

Interventions

TetrahydrocannabinolDRUG

Participants will be randomly assigned to receive an oral dose of 10 mg of THC, 20 mg of THC, or placebo.

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Marijuana dependent volunteers.

You may qualify if:

  • Meets DSM-IV diagnosis criteria for marijuana dependence
  • Able to read and write in English
  • Positive urine test for marijuana
  • If female, must be willing to use contraception throughout the study

You may not qualify if:

  • Meets DSM-IV diagnosis criteria for a psychiatric illness
  • History of a psychotic disorder
  • Seeking treatment for marijuana dependence
  • Neurologic disease, including structural brain abnormalities (e.g., neoplasms), stroke, seizures, infectious disease, head trauma resulting in unconsciousness, or evidence of neurologic illness resulting from HIV/AIDS
  • Cardiovascular disease, including edema, chest pain or palpitations after exertion or drug use, myocardial infarction (heart attack), systolic blood pressure greater than 160 mm Hg or less than 95 mm Hg, or diastolic blood pressure greater than 95 mm Hg
  • Pulmonary disease, including apnea, cor pulmonale, tuberculosis, dyspnea, orthopnea, or tachypnea
  • Systemic disease, including endocrinopathies, kidney or liver failure, hypothyroidism, adrenocortical insufficiency, or autoimmune disease involving the central nervous system
  • Currently dependent on any drug other than marijuana or nicotine
  • Cognitively impaired
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48207, United States

Location

Related Publications (2)

  • Lundahl LH, Greenwald MK. Magnitude and duration of cue-induced craving for marijuana in volunteers with cannabis use disorder. Drug Alcohol Depend. 2016 Sep 1;166:143-9. doi: 10.1016/j.drugalcdep.2016.07.004. Epub 2016 Jul 18.

    PMID: 27436749DERIVED

  • Lundahl LH, Greenwald MK. Effect of oral THC pretreatment on marijuana cue-induced responses in cannabis dependent volunteers. Drug Alcohol Depend. 2015 Apr 1;149:187-93. doi: 10.1016/j.drugalcdep.2015.01.046. Epub 2015 Feb 11.

    PMID: 25725933DERIVED

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Leslie H. Lundahl

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

December 1, 2005

Study Completion

October 1, 2009

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

US(1)