Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Stress and Marijuana Cue-elicited Craving and Reactivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00613405
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : May 4, 2012
Last Update Posted : April 30, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Cannabis Use Disorders
Interventions Other: Stress + cue exposure
Other: No stress + cue exposure
Enrollment 87
Recruitment Details Participants were recruited primarily through community advertisements between January 2008 and June 2009.
Pre-assignment Details  
Arm/Group Title Stress No Stress
Hide Arm/Group Description Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues. Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
Period Title: Overall Study
Started 45 42
Completed 45 42
Not Completed 0 0
Arm/Group Title Stress No Stress Total
Hide Arm/Group Description Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues. Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues. Total of all reporting groups
Overall Number of Baseline Participants 45 42 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 42 participants 87 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
 100.0%
42
 100.0%
87
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 42 participants 87 participants
Female
16
  35.6%
13
  31.0%
29
  33.3%
Male
29
  64.4%
29
  69.0%
58
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 42 participants 87 participants
45 42 87
1.Primary Outcome
Title Subjective Craving of Marijuana
Hide Description Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving
Time Frame approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stress No Stress
Hide Arm/Group Description:
Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
Overall Number of Participants Analyzed 45 42
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
50.5  (1.6) 52.3  (1.6)
2.Secondary Outcome
Title Physiological Assessments: Serum Cortisol, ACTH, BP, HR, and GSR
Hide Description [Not Specified]
Time Frame ~ 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)
Hide Description [Not Specified]
Time Frame ~2 hours
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Current Mood as Assessed by the Mood Form
Hide Description [Not Specified]
Time Frame ~2 hours
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stress No Stress
Hide Arm/Group Description Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues. Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
All-Cause Mortality
Stress No Stress
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Stress No Stress
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/42 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stress No Stress
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/42 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aimee McRae-Clark, PharmD
Organization: Medical University of South Carolina
Phone: 843-792-5126
EMail: mcraeal@musc.edu
Layout table for additonal information
Responsible Party: Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00613405    
Other Study ID Numbers: HR#17195
R21DA022424 ( U.S. NIH Grant/Contract )
R21DA022424-01A1 ( U.S. NIH Grant/Contract )
First Submitted: February 11, 2008
First Posted: February 13, 2008
Results First Submitted: June 15, 2011
Results First Posted: May 4, 2012
Last Update Posted: April 30, 2013