Trial Outcomes & Findings for Stress and Marijuana Cue-elicited Craving and Reactivity (NCT NCT00613405)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

87 participants

Primary outcome timeframe

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

Results posted on

2013-04-30

Participant Flow

Participants were recruited primarily through community advertisements between January 2008 and June 2009.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	45	42
Overall Study COMPLETED	45	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stress and Marijuana Cue-elicited Craving and Reactivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stress n=45 Participants 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 n=42 Participants 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 n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	42 Participants n=7 Participants	87 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	42 participants n=7 Participants	87 participants n=5 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Stress n=45 Participants 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 n=42 Participants 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.
Subjective Craving of Marijuana	50.5 Scores on a Scale Standard Deviation 1.6	52.3 Scores on a Scale Standard Deviation 1.6

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: ~2 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: ~2 hours

Outcome measures

Outcome data not reported

Adverse Events

Stress

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Stress

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aimee McRae-Clark, PharmD

Medical University of South Carolina

Phone: 843-792-5126

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place