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Stress and Marijuana Cue-elicited Craving and Reactivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 11, 2008
First Posted Date  ICMJE February 13, 2008
Results First Submitted Date  ICMJE June 15, 2011
Results First Posted Date  ICMJE May 4, 2012
Last Update Posted Date April 30, 2013
Study Start Date  ICMJE January 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
Subjective craving of marijuana, defined as the expectancy sub-domain score on the Marijuana Craving Questionnaire [ Time Frame: - ~ 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues). ]
Change History Complete list of historical versions of study NCT00613405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
  • 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). ]
  • Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI) [ Time Frame: ~2 hours ]
  • Current Mood as Assessed by the Mood Form [ Time Frame: ~2 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stress and Marijuana Cue-elicited Craving and Reactivity
Official Title  ICMJE Stress and Marijuana Cue-elicited Craving and Reactivity
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Cannabis Use Disorders
Intervention  ICMJE
  • 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
  • Other: No stress + cue exposure
    Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues).
    Other Name: marijuana cue exposure, neutral cue exposure
Study Arms  ICMJE
  • Experimental: Stress + cue exposure
    Individuals were exposed to the Trier Social Stress Test (TSST) as well as neutral cues and marijana cues.
    Intervention: Other: Stress + cue exposure
  • Experimental: No stress + cue exposure
    Individuals were not exposed to a stress test, but were exposed to neutral cues and marijuana cues.
    Intervention: Other: No stress + cue exposure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2012)
87
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2008)
60
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00613405
Other Study ID Numbers  ICMJE HR#17195
R21DA022424 ( U.S. NIH Grant/Contract )
R21DA022424-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aimee McRae-Clark, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Aimee L McRae, PharmD, BCPP Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP