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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 16, 2005 | ||||
| Last Updated Date | October 15, 2009 | ||||
| Start Date ICMJE | December 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Marijuana craving [ Time Frame: Measured throughout the cue exposure session ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Marijuana craving; measured throughout study | ||||
| Change History | Complete list of historical versions of study NCT00218504 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Responses to Marijuana-Related Cues Versus Neutral Cues in Adults Taking Tetrahydrocannabinol (THC) - 2 | ||||
| Official Title ICMJE | Cue Reactivity Model for Assessing Pharmacologic Intervention in Treatment of Cannabis Use Disorders (Study 2) | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE | Marijuana Abuse | ||||
| Intervention ICMJE | Drug: Tetrahydrocannabinol | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 45 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00218504 | ||||
| Responsible Party | Leslie Lundahl, PhD, Wayne State University | ||||
| Study ID Numbers ICMJE | NIDA-19236-2, R21-DA019236-2, DPMCDA | ||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators ICMJE | Wayne State University | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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