Clinical trial NCT00613405: Stress and Marijuana Cue-elicited Craving and Reactivity
Official title: Stress and Marijuana Cue-elicited Craving and Reactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use Disorders
Keywords: substance-related disorders
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-02-13
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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)

Primary outcomes:
measure: Subjective Craving of Marijuana
timeFrame: approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).
Secondary outcomes:
measure: Physiological Assessments: Serum Cortisol, ACTH, BP, HR, and GSR
timeFrame: ~ 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).
measure: Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)
timeFrame: ~2 hours
measure: Current Mood as Assessed by the Mood Form
timeFrame: ~2 hours
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Aimee L McRae, PharmD, BCPP
role: PRINCIPAL_INVESTIGATOR
References: