Cannabis Use DisordersNCT00613405
Stress and Marijuana Cue-elicited Craving and Reactivity
A study testing Stress + cue exposure and No stress + cue exposure in people with Cannabis Use Disorders, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cannabis Use Disorders
- What is being tested?
- Stress + cue exposure and No stress + cue exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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.
- Conditions
- Cannabis Use Disorders
- Being tested
- Stress + cue exposure, No stress + cue exposure
- Keywords
- substance-related disorders
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress + cue exposureOther
Also called Stress stask, TSST
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 exposureOther
Also called marijuana cue exposure, neutral cue exposure
Neutral and marijuana-associated cue exposure (scripted imagery, in vivo cues).
| Study group | Role | What they receive |
|---|---|---|
| Stress + cue exposure | Experimental | Individuals were exposed to the Trier Social Stress Test (TSST) as well as neutral cues and marijana cues. Receives: Other: Stress + cue exposure |
| No stress + cue exposure | Experimental | Individuals were not exposed to a stress test, but were exposed to neutral cues and marijuana cues. Receives: Other: No stress + cue exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Craving of Marijuana
Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving
Measured: approx 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).
Secondary outcomes (3)
Physiological Assessments: Serum Cortisol, ACTH, BP, HR, and GSR
Measured: ~ 2.5 hours (before, during and after exposure to stressor condition as well as exposure to neutral and marijuana-associated cues).
Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)
Measured: ~2 hours
Current Mood as Assessed by the Mood Form
Measured: ~2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cannabis Use DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Aimee McRae-Clark, Medical University of South Carolina
- Investigators
- Aimee L McRae, PharmD, BCPP, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613405
- Sponsor's protocol ID
- HR#17195
- Other IDs
- R21DA022424, R21DA022424-01A1
- Status last verified
- Apr 2013
- First submitted
- 11 Feb 2008
- Last updated
- 30 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Marijuana Cue-elicited Craving and Reactivity
- ClinicalTrials.gov ID
- NCT00613405
- Acronym / sponsor ID
- HR#17195
- Conditions
- Cannabis Use Disorders
- Keywords
- substance-related disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Posted 4 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress + cue exposure | Experimental | Other: Stress + cue exposureIndividuals were exposed to the Trier Social Stress Test (TSST) as well as neutral cues and marijana cues. |
| No stress + cue exposure | Experimental | Other: No stress + cue exposureIndividuals were not exposed to a stress test, but were exposed to neutral cues and marijuana cues. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress + cue exposureAlso: Stress stask, TSSTTrier 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. | Other | Stress + cue exposure |
| No stress + cue exposureAlso: marijuana cue exposure, neutral cue exposureNeutral and marijuana-associated cue exposure (scripted imagery, in vivo cues). | Other | No stress + cue exposure |
Primary outcome
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).
Defined as the score on the Marijuana Craving Questionnaire (MCQ), range 7-84, higher scores indicate more craving
3 secondary outcomes
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).
Feelings of Stress/Anxiety as Measured by the State-Trait Inventory (STAI)
Time frame: ~2 hours
Current Mood as Assessed by the Mood Form
Time frame: ~2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aimee L McRae, PharmD, BCPP principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress + cue exposure and No stress + cue exposure in people with Cannabis Use Disorders, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.