Stress and Marijuana Cue-elicited Craving and Reactivity

NCT00613405 | Completed Results

• 3 other identifiers: HR#17195R21DA022424R21DA022424-01A1
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorders

Keywords

substance-related disorders

Outcome Measures

Primary Outcomes (1)

• Subjective Craving of Marijuana

  Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving

  approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).

Secondary Outcomes (3)

• Physiological Assessments: Serum Cortisol, ACTH, BP, HR, and GSR

  ~ 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)

  ~2 hours

• Current Mood as Assessed by the Mood Form

  ~2 hours

Study Arms (2)

Stress + cue exposure

EXPERIMENTAL

Individuals were exposed to the Trier Social Stress Test (TSST) as well as neutral cues and marijana cues.

Other: Stress + cue exposure

No stress + cue exposure

EXPERIMENTAL

Individuals were not exposed to a stress test, but were exposed to neutral cues and marijuana cues.

Other: No stress + cue exposure

Interventions

Stress + cue exposure OTHER

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.

Also known as: Stress stask, TSST

Stress + cue exposure

No stress + cue exposure OTHER

Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues).

Also known as: marijuana cue exposure, neutral cue exposure

No stress + cue exposure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Limitations and Caveats

A control group of non-marijuana dependent individuals was not included, which may have provided further insight into the interactions of stress and cues both in the presence and absence of addiction.

Results Point of Contact

• Title: Aimee McRae-Clark, PharmD
• Organization: Medical University of South Carolina

mcraeal@musc.edu

843-792-5126

Study Officials

• Aimee L McRae, PharmD, BCPP

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 30, 2013
• Results First Posted: May 4, 2012

Record last verified: 2013-04

Locations

US (1)