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Stress and Marijuana Cue-elicited Craving and Reactivity

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ClinicalTrials.gov Identifier: NCT00613405
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : May 4, 2012
Last Update Posted : April 30, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorders Other: Stress + cue exposure Other: No stress + cue exposure Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Stress and Marijuana Cue-elicited Craving and Reactivity
Study Start Date : January 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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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.
 Other: Stress + cue exposure
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 Name: Stress stask, TSST
Experimental: No stress + cue exposure
Individuals were not exposed to a stress test, but were exposed to neutral cues and marijuana cues.
 Other: No stress + cue exposure
Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues).
Other Name: marijuana cue exposure, neutral cue exposure


Outcome Measures
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Primary Outcome Measures :
  1. 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). ]
    Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving


Secondary Outcome Measures :
  1. 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. Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI) [ Time Frame: ~2 hours ]
  3. Current Mood as Assessed by the Mood Form [ Time Frame: ~2 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613405


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Aimee L McRae, PharmD, BCPP Medical University of South Carolina
More Information
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Responsible Party: Aimee McRae-Clark, Associate Professor of Psychiatry, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00613405     History of Changes
Other Study ID Numbers: HR#17195
R21DA022424 ( U.S. NIH Grant/Contract )
R21DA022424-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2008    Key Record Dates
Results First Posted: May 4, 2012
Last Update Posted: April 30, 2013
Last Verified: April 2013
Keywords provided by Aimee McRae-Clark, Medical University of South Carolina:
substance-related disorders
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders