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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00613405 |
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Date of registration:
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11/02/2008 |
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Primary sponsor: |
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Public title:
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Stress and Marijuana Cue-elicited Craving and Reactivity
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Scientific title:
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Stress and Marijuana Cue-elicited Craving and Reactivity |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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87 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00613405 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Aimee L McRae, PharmD, BCPP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of South Carolina |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Meets Diagnostic and Statistical Methods (DSM)-IV Criteria for Marijuana Dependence
- Between the ages of 18 and 65
- Must abstain from marijuana use the day of testing and other drug use three days
prior to testing
Exclusion Criteria:
- Must not be taking any psychoactive medication, or medication that alters the
hypothalamic pituitary adrenal (HPA) Axis functioning
- Must not be taking any medications that alter heart rate or skin conductance
monitoring
- Cannot meet criteria for current major Axis I disorder (may alter response to stress)
- Cannot be morbidly obese (Body Mass Index >39)
- Cannot meet current abuse or dependence criteria of other substances in past 90 days
- Must not have a medical condition that impacts HPA functioning (Hypertension, chronic
pain, Addison's disease)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cannabis Use Disorders
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Intervention(s)
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Other: No stress + cue exposure
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Other: Stress + cue exposure
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Primary Outcome(s)
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Subjective Craving of Marijuana
[Time Frame: approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).]
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Secondary Outcome(s)
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Current Mood as Assessed by the Mood Form
[Time Frame: ~2 hours]
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Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)
[Time Frame: ~2 hours]
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Physiological Assessments: Serum Cortisol, ACTH, BP, HR, and GSR
[Time Frame: ~ 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).]
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Secondary ID(s)
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HR#17195
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R21-DA022424-01A1
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R21DA022424
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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