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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Wayne State University |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00218504 |
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.
Condition | Intervention | Phase |
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Marijuana Abuse |
Drug: Tetrahydrocannabinol |
Phase I |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Cue Reactivity Model for Assessing Pharmacologic Intervention in Treatment of Cannabis Use Disorders (Study 2) |
Estimated Enrollment: | 20 |
Study Start Date: | December 2005 |
Marijuana is the most commonly used illegal drug in the United States; more than 2 million Americans either abuse or are dependent on the drug. Therefore, there is a clear need for treatment options. Past research on marijuana treatments has focused on alleviating withdrawal symptoms. Minimal focus has been placed on how altering craving effects may play a role in treating marijuana addiction. Treatment with THC, a component of marijuana that causes the "high" sensation, may reduce marijuana cravings. This study will evaluate the subjective and physiological responses to marijuana-related cues versus non marijuana-related cues in marijuana users who have been pre-treated with THC.
Participants will attend three 6-hour sessions, each separated by at least 7 days. Prior to each testing session, participants will spend the night at the Psychiatric and Addiction Research Center at Detroit Receiving Hospital in order to ensure no alcohol or drug use during the 12 hours preceding the session. Participants will be randomly assigned to receive an oral dose of 10 mg of THC, 20 mg of THC, or placebo. They will then undergo a cue exposure test during which they will be shown a nature video and will be asked to handle and smell various items; these will act as neutral, non marijuana-related cues. Next, the participants will watch a video of individuals smoking marijuana and will be asked to handle and smell marijuana-related items; these will act as the marijuana-related cues. Heart rate and skin temperature will be monitored continuously throughout each session with the use of electrodes and a skin thermometer. Prior to and after the cue exposure sessions blood pressure will be measured and questionnaires will be administered to assess drug cravings as well as related mood states. Prior to leaving the clinical center, the participants' vital signs will be evaluated to ensure that any cue-related physiological changes have returned to normal. Following the end of the study session, participants will have the option of talking to a clinician experienced in dealing with drug cravings.
Ages Eligible for Study: | 21 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Marijuana dependent volunteers.
Inclusion Criteria:
Exclusion Criteria:
Contact: Ken Bates | 1-888-457-3744 | kbates@med.wayne.edu |
United States, Michigan | |
Wayne State University | Recruiting |
Detroit, Michigan, United States, 48207 | |
Contact: Leslie H. Lundahl 313-993-1374 llundahl@med.wayne.edu |
Principal Investigator: | Leslie H. Lundahl | Wayne State University |
Responsible Party: | Wayne State University ( Leslie Lundahl, PhD ) |
Study ID Numbers: | NIDA-19236-2, R21-19236-2, DPMC |
Study First Received: | September 16, 2005 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00218504 |
Health Authority: | United States: Federal Government |
Tetrahydrocannabinol Mental Disorders Substance-Related Disorders Disorders of Environmental Origin Marijuana Abuse |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Hallucinogens Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |