Expired Study
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Charleston, South Carolina 29425


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.


Study summary:

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.


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)


Study is Available At:


Original ID:

HR#17195


NCT ID:

NCT00613405


Secondary ID:

R21DA022424


Study Acronym:


Brief Title:

Stress and Marijuana Cue-elicited Craving and Reactivity


Official Title:

Stress and Marijuana Cue-elicited Craving and Reactivity


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medical University of South Carolina


Oversight Authority:

  • United States: Federal Government
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

87


Enrollment Type:

Actual


Overall Contact Information

Official Name:Aimee L McRae, PharmD, BCPP
Principal Investigator
Medical University of South Carolina

Study Dates

Start Date:January 2008
Completion Date:May 2009
Completion Type:Actual
Primary Completion Date:May 2009
Primary Completion Type:Actual
Verification Date:May 2012
Last Changed Date:May 8, 2012
First Received Date:February 11, 2008
First Results Date:June 15, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Current Mood as Assessed by the Mood Form
Time Frame:~2 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)
Time Frame:~2 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Subjective Craving of Marijuana
Time Frame:approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neu
Safety Issues:False
Description:Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving

Study Interventions

Intervention Type:Other
Name:Stress + cue exposure
Description: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.
Arm Name:Stress + cue exposure
Other Name:Stress stask, TSST
Intervention Type:Other
Name:No stress + cue exposure
Description:Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues).
Arm Name:No stress + cue exposure
Other Name:marijuana cue exposure, neutral cue exposure

Study Arms

Study Arm Type:Experimental
Arm Name:Stress + cue exposure
Description:Individuals were exposed to the Trier Social Stress Test (TSST) as well as neutral cues and marijana cues.
Study Arm Type:Experimental
Arm Name:No stress + cue exposure
Description:Individuals were not exposed to a stress test, but were exposed to neutral cues and marijuana cues.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Medical University of South Carolina
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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