Stress and Marijuana Cue-elicited Craving and Reactivity
This study has been completed.
Sponsor:
Medical University of South Carolina
Collaborator:
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00613405
First received: February 11, 2008
Last updated: April 23, 2013
Last verified: April 2013
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Results First Received: June 15, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label |
| Condition: |
Cannabis Use Disorders |
| Interventions: |
Other: Stress + cue exposure Other: No stress + cue exposure |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Participants were recruited primarily through community advertisements between January 2008 and June 2009. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Stress | 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. |
| No Stress | 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. |
Participant Flow: Overall Study
| Stress | No Stress | |
|---|---|---|
| STARTED | 45 | 42 |
| COMPLETED | 45 | 42 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Stress | 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. |
| No Stress | 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 | Total of all reporting groups |
Baseline Measures
| Stress | No Stress | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
45 | 42 | 87 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 42 | 87 |
| >=65 years | 0 | 0 | 0 |
|
Gender
[units: participants] |
|||
| Female | 16 | 13 | 29 |
| Male | 29 | 29 | 58 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 45 | 42 | 87 |
Outcome Measures
| 1. Primary: | Subjective Craving of Marijuana [ Time Frame: approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues). ] |
| 2. Secondary: | 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 and marijuana-associated cues). ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 3. Secondary: | Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI) [ Time Frame: ~2 hours ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 4. Secondary: | Current Mood as Assessed by the Mood Form [ Time Frame: ~2 hours ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| 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:
Name/Title: Aimee McRae-Clark, PharmD
Organization: Medical University of South Carolina
phone: 843-792-5126
e-mail: mcraeal@musc.edu
Organization: Medical University of South Carolina
phone: 843-792-5126
e-mail: mcraeal@musc.edu
No publications provided
| Responsible Party: | Aimee McRae-Clark, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT00613405 History of Changes |
| Other Study ID Numbers: | HR#17195, R21DA022424, R21-DA022424-01A1 |
| Study First Received: | February 11, 2008 |
| Results First Received: | June 15, 2011 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |