Stress and Marijuana Cue-elicited Craving and Reactivity
This study has been completed.
Sponsor:
Medical University of South Carolina
Collaborator:
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00613405
First received: February 11, 2008
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
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 | Intervention |
|---|---|
|
Cannabis Use Disorders |
Other: Stress + cue exposure Other: No stress + cue exposure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Stress and Marijuana Cue-elicited Craving and Reactivity |
Resource links provided by NLM:
Further study details as provided by Medical University of South Carolina:
Primary Outcome Measures:
- 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). ] [ Designated as safety issue: No ]Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving
Secondary Outcome Measures:
- 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). ] [ Designated as safety issue: No ]
- Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI) [ Time Frame: ~2 hours ] [ Designated as safety issue: No ]
- Current Mood as Assessed by the Mood Form [ Time Frame: ~2 hours ] [ Designated as safety issue: No ]
| Enrollment: | 87 |
| Study Start Date: | January 2008 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613405
Locations
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
Sponsors and Collaborators
Medical University of South Carolina
Investigators
| Principal Investigator: | Aimee L McRae, PharmD, BCPP | Medical University of South Carolina |
More Information
No publications provided
| 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, R21-DA022424-01A1 |
| Study First Received: | February 11, 2008 |
| Results First Received: | June 15, 2011 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Medical University of South Carolina:
|
substance-related disorders |
ClinicalTrials.gov processed this record on May 16, 2013