Stress and Marijuana Cue-Elicited Craving and Reactivity - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00613405

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
Marijuana Use Disorders	Other: TSST Other: Cue exposure

MedlinePlus related topics: Marijuana

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Stress and Marijuana Cue-Elicited Craving and Reactivity

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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). ] [ Designated as safety issue: No ]

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 ]

Estimated Enrollment:	60
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TSST: Experimental	Other: TSST Trier Social Stress Task: subject is asked to give a talk and perform a math task in front of an audience
Cue exposure: Experimental	Other: Cue exposure Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues)

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 DSM 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 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 (BMI >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

Contacts

Contact: Aimee L McRae, PharmD, BCPP

843-792-5216

mcraeal@musc.edu

Locations

United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Aimee L McRae, PharmD, BCPP

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Aimee L McRae, PharmD, BCPP

Medical University of South Carolina

More Information

No publications provided

Responsible Party:	Medical University of South Carolina ( Aimee L. McRae, Pharm.D., BCPP )
Study ID Numbers:	HR#17195, R21-DA022424-01A1
Study First Received:	February 11, 2008
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00613405 History of Changes
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by National Institute on Drug Abuse (NIDA):

substance-related disorders

Study placed in the following topic categories:

Smoking
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

Stress
Marijuana Smoking
Marijuana Abuse

Additional relevant MeSH terms:

Habits
Smoking
Mental Disorders
Substance-Related Disorders

Disorders of Environmental Origin
Marijuana Smoking
Marijuana Abuse

ClinicalTrials.gov processed this record on May 07, 2009