- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00613405
Stress and Marijuana Cue-elicited Craving and Reactivity
April 23, 2013 updated by: Aimee McRae-Clark, Medical University of South Carolina
The purpose of this study is to explore the interaction between stress and marijuana cues, in hopes that it may lead to the development of new treatments for marijuana dependence.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Although use of marijuana is widespread, little research has focused on the treatment of marijuana use disorders or on predictors of relapse.
Although several factors contributing to relapse have been explored in other dependencies (i.e., alcohol, cocaine), little research has focused on drug cue-related or stress-induced relapse in marijuana-dependent individuals.
Cue reactivity is a construct measured in a laboratory procedure where an individual's subjective, behavioral, and physiological responses are assessed following exposure to drug-related environmental cues or stressors.
Investigating the effects of drug-related environmental cues and stress in marijuana-dependent individuals will be useful in guiding treatment development.
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stress + cue exposure
Individuals were exposed to the Trier Social Stress Test (TSST) as well as neutral cues and marijana cues.
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Trier Social Stress Task(TSST): subject is asked to give a talk and perform a math task in front of an audience, follwed by neutral and marijuana cue exposure.
Other Names:
|
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Experimental: No stress + cue exposure
Individuals were not exposed to a stress test, but were exposed to neutral cues and marijuana cues.
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Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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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Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving
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approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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).
|
~ 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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Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)
Time Frame: ~2 hours
|
~2 hours
|
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Current Mood as Assessed by the Mood Form
Time Frame: ~2 hours
|
~2 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Aimee L McRae, PharmD, BCPP, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
February 11, 2008
First Submitted That Met QC Criteria
February 11, 2008
First Posted (Estimate)
February 13, 2008
Study Record Updates
Last Update Posted (Estimate)
April 30, 2013
Last Update Submitted That Met QC Criteria
April 23, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR#17195
- R21DA022424 (U.S. NIH Grant/Contract)
- R21DA022424-01A1 (U.S. NIH Grant/Contract)
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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