- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218478
Evaluating Responses to Drug-Related Cues Versus Neutral Cues to Understand the Effects of Marijuana Craving - 1
Cue Reactivity Model for Assessing Pharmacologic Intervention in Treatment of Cannabis Use Disorders (Study 1)
Study Overview
Status
Conditions
Intervention / Treatment
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. The development of a medication to reduce marijuana use and prevent drug relapse by lessening withdrawal symptoms has been a primary focus of research. However, there has been little emphasis on evaluating the efficacy of a treatment that specifically reduces marijuana cravings. This study will evaluate the subjective and physiological responses to marijuana-related cues versus non marijuana-related cues in order to better understand the effects of marijuana cravings.
Participants will be divided into two groups. Group 1 will consist of 20 individuals diagnosed with marijuana dependence; Group 2 will consist of individuals matched by age range, gender and race to Group 1, and who are healthy volunteers and do not use marijuana or who report limited marijuana exposure. Participants in Group 1 will spend one night at the Psychiatric and Addiction Research Center at Detroit Receiving Hospital to control for alcohol and drug use for 12 hours preceding the next day's 2-hour study session. Participants in Group 2 are not required to spend the night, but are tested for drugs and alcohol prior to the session. During the study session, both groups will be shown a nature video and will be asked to handle and smell various items; these will act as the 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 the cue sessions with the use of electrodes and a skin thermometer. Prior to and after the cue 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 laboratory, the participants' vital signs will be evaluated to ensure that any cue-related physiological changes have returned to normal. Participants will have the option of talking to a clinician experienced in dealing with drug cravings following the end of the study session.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48207
- Wayne State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Meets DSM-IV diagnosis criteria for marijuana dependence. Participants enrolled in the control group should not meet DSM-IV diagnosis criteria for any Axis I disorder, and should not use marijuana or have had limited marijuana exposure.
- Reads and writes English
- If female, willing to use adequate contraception throughout the study
Exclusion criteria:
- 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 mmHg or less than 95 mmHg, or diastolic blood pressure greater than 95 mmHg
- Pulmonary disease, including apnea, cor pulmonale, tuberculosis, dyspnea, orthopnea, or tachypnea
- Systemic disease, including endocrinopathies, kidney or liver failure, hypothyroidism, adrenocortical insufficiency, or an autoimmune disease involving the central nervous system
- Currently dependent on any drug other than marijuana or nicotine
- Cognitively impaired
- Pregnant or breastfeeding
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-19236-1
- DPMCDA (Other Identifier: NIDA)
- R21DA019236-01 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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