Stress and Marijuana Cue-elicited Craving and Reactivity

Cannabis Use Disorders Clinical Trial

Official title:

Stress and Marijuana Cue-elicited Craving and Reactivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613405
• Other study ID #: HR#17195
• Secondary ID: R21DA022424R21DA
• Status: Completed
• Phase: N/A
• First received: February 11, 2008
• Last updated: April 23, 2013
• Start date: January 2008
• Est. completion date: May 2009

Study information

• Verified date: April 2013
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cannabis Use Disorders

Intervention

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.
• No stress + cue exposure
Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues).

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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).	No
Secondary	Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)		~2 hours	No
Secondary	Current Mood as Assessed by the Mood Form		~2 hours	No