Marijuana DependenceNCT01179425
Sex Differences in Attentional Bias in Marijuana-dependent Individuals
A study testing Cognitive stressor in people with Marijuana Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to explore sex differences in cognitive functioning and responses to marijuana-related items, and to determine whether stress impacts these measures. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Dependence
- What is being tested?
- Cognitive stressor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria will include subjects between the ages of 18-65 who meet full DSM-IV criteria for marijuana dependence and non-dependent controls.
Who cannot join
- Exclusion criteria will include medications that may affect cognitive or HPA-axis functioning
- Current depression
- Bipolar disorder
- Attention deficit hyperactivity disorder
- History of psychosis
- Suicidal or homicidal intent
- Significant cognitive deficits
- Dependence on any substance other than marijuana, nicotine, or caffeine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina, Dept. of Psychiatry/Clinical Neuroscience Division
Charleston, South Carolina, 29425
About this study
Official title: Sex Differences in Attentional Bias and Cognitive Functioning in Response to Stress in Marijuana-dependent Individuals
The purpose of this study is to explore sex differences in cognitive functioning and responses to marijuana-related items, and to determine whether stress impacts these measures.
Hypothesis 1: Attentional bias will be greater for marijuana cues in male marijuana-dependent subjects relative to female marijuana-dependent or non-dependent male controls.
Hypothesis 2: Marijuana-dependent females will exhibit greater stress-induced changes in attentional bias and cognitive functioning than marijuana-dependent males.
Read the detailed description
Ample evidence implicates both environmental cues and negative affective states in maintaining drug use or triggering relapse. However, although 'craving' is believed to drive continued drug use, it is not well understood how cognitive processes influence craving and relapse, nor how they may differ between the sexes. Therefore, the goal of this study protocol is to provide insight into sex differences in the cognitive aspects of drug craving and to assess the impact of stress on attentional bias for drug-related cues as well as on the availability of cognitive resources.
- Conditions
- Marijuana Dependence
- Being tested
- Cognitive stressor
- Keywords
- marijuana, dependence, cognition, stress
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive stressorOther
The Paced Auditory Serial Addition Task (PASAT-C), has been modified for use as a computerized laboratory-based stressor. Single digits are presented, and the patient must add each new digit to the one immediately prior to it and click on the appropriate answer. Failure to do so in the allotted time results in a noxious error sound.
| Study group | Role | What they receive |
|---|---|---|
| non-marijuana dependent controls | Active comparator | Not described Receives: Other: Cognitive stressor |
| Marijuana-dependent subjects | Experimental | Not described Receives: Other: Cognitive stressor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures will be obtained from the auditory odd-ball task: differences while viewing the marijuana vs neutral video in reaction time (msec), errors of omission (%), and errors of commission (%).
Measured: ~ 3 hours
Secondary outcomes (1)
Secondary measures include subjective (craving and stress), physiological (heart rate and skin conductance), and stress hormone level (cortisol) assessments.
Measured: ~ 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startAug 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana DependenceStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Kimber L Price, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179425
- Sponsor's protocol ID
- HR# 19292
- Status last verified
- Apr 2011
- First submitted
- 17 Nov 2009
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Attentional Bias and Cognitive Functioning in Response to Stress in Marijuana-dependent Individuals
- ClinicalTrials.gov ID
- NCT01179425
- Acronym / sponsor ID
- HR# 19292
- Conditions
- Marijuana Dependence
- Keywords
- marijuana, dependence, cognition, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
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 sex differences in cognitive functioning and responses to marijuana-related items, and to determine whether stress impacts these measures.
Hypothesis 1: Attentional bias will be greater for marijuana cues in male marijuana-dependent subjects relative to female marijuana-dependent or non-dependent male controls.
Hypothesis 2: Marijuana-dependent females will exhibit greater stress-induced changes in attentional bias and cognitive functioning than marijuana-dependent males.
Detailed description
Ample evidence implicates both environmental cues and negative affective states in maintaining drug use or triggering relapse. However, although 'craving' is believed to drive continued drug use, it is not well understood how cognitive processes influence craving and relapse, nor how they may differ between the sexes. Therefore, the goal of this study protocol is to provide insight into sex differences in the cognitive aspects of drug craving and to assess the impact of stress on attentional bias for drug-related cues as well as on the availability of cognitive resources.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-marijuana dependent controls | Active comparator | Other: Cognitive stressor |
| Marijuana-dependent subjects | Experimental | Other: Cognitive stressor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria will include subjects between the ages of 18-65 who meet full DSM-IV criteria for marijuana dependence and non-dependent controls.
Key exclusion criteria (8 listed)
- Exclusion criteria will include medications that may affect cognitive or HPA-axis functioning
- Current depression
- Bipolar disorder
- Attention deficit hyperactivity disorder
- History of psychosis
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 |
|---|---|---|
| Cognitive stressorThe Paced Auditory Serial Addition Task (PASAT-C), has been modified for use as a computerized laboratory-based stressor. Single digits are presented, and the patient must add each new digit to the one immediately prior to it and click on the appropriate answer. Failure to do so in the allotted time results in a noxious error sound. | Other | Marijuana-dependent subjects, non-marijuana dependent controls |
Primary outcome
Primary outcome measures will be obtained from the auditory odd-ball task: differences while viewing the marijuana vs neutral video in reaction time (msec), errors of omission (%), and errors of commission (%).
Time frame: ~ 3 hours
1 secondary outcome
Secondary measures include subjective (craving and stress), physiological (heart rate and skin conductance), and stress hormone level (cortisol) assessments.
Time frame: ~ 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
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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.
Kimber L Price, PhD 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 Cognitive stressor in people with Marijuana Dependence, 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 1 inclusion and 8 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 14 Apr 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary outcome measures will be obtained from the auditory odd-ball task: differences while viewing the marijuana vs neutral video in reaction time (msec), errors of omission (%), and errors of commission (%). (time frame: ~ 3 hours). 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 14 Apr 2011.