Alcohol Approach/Avoidance TaskMJ-AATNCT02723149
Marijuana Approach Bias Retraining and Neural Response in Youth
A study testing Marijuana Approach Avoidance Training in people with Alcohol Approach/Avoidance Task and Sham Approach/Avoidance Task, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention reduces cannabis use compared to a control condition containing no active components of AAT. Read more about this study
- Who is it for?
- Ages 16 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Approach/Avoidance Task, Sham Approach/Avoidance Task
- What is being tested?
- Marijuana Approach Avoidance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Oct 2017
- 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 16 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- between age 16 and 21
- having >50 lifetime marijuana use episodes and a pattern of at least weekly marijuana use for the past year (>1+/week for 52 weeks) at study entry.
Who cannot join
- not having a parent to consent (for those under age 18)
- prenatal alcohol (>2 drinks on an occasion or >4 drinks in a week) or any tobacco or illicit drug exposure
- premature birth (<34 weeks gestation), birth weight <5 lbs, or other gestational or perinatal complications
- history of a serious medical or neurological problems that could affect blood oxygen level dependent (BOLD) response, brain development, or study participation, including diabetes and recurrent migraine
- current severe Diagnostic and Statistical Manual of Mental Disorders (DSM-5) major Axis I psychiatric disorder (i.e., exclude participants with bipolar disorder, psychotic disorder)
- use of any illicit substance (e.g., cocaine, methamphetamines) other than alcohol or marijuana > 100 times
Show all 14Show fewer
- history of major neurological disorder or head trauma (with loss of consciousness >10 minutes)
- history of learning disability, pervasive developmental disorder, or other condition requiring special education
- current use of medications that affect cerebral blood flow
- non-correctable visual or hearing problems
- non-fluent in English
- MRI contraindications (e.g., braces, claustrophobia, irremovable metal implants or piercings)
- pregnant on day of scan
- intake of psychoactive medication as tested by urine drug screen.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention reduces cannabis use compared to a control condition containing no active components of AAT. Adolescent heavy MJ users (N=40, ages 16-21) will be randomly assigned to MJ-AAT (n=20) or control condition (MJ-Sham, n=20) for three weeks. The MJ-AAT includes six sessions designed to reduce action tendencies to approach marijuana. The MJ-Sham includes six MJ-AAT-sham conditions. Substance use and cognitive assessment will identify changes in MJ use patterns and mechanisms of treatment outcomes. Additionally, using an functional magnetic resonance imaging marijuana cue reactivity task, we will determine differences in neural response in reward regions before and after 3 weeks of either AAT or sham treatment.
- Being tested
- Marijuana Approach Avoidance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marijuana Approach Avoidance TrainingBehavioural
Approach Avoidance Training (AAT) is a novel computerized procedure that modifies implicit approach tendencies by training individuals to selectively avoid drug- related stimuli, thereby overriding habitual approach tendencies. Participants are randomized to either the treatment or sham condition. Treatment duration involves 6 training sessions of approximately 15 minutes each (400 trials). AAT requires minimal training and involves only a computer and a joystick, in which participants are either pulling or pushing the joystick when different marijuana or non-marijuana images are displayed with either yellow (pull) or blue (push) border.
| Study group | Role | What they receive |
|---|---|---|
| Approach Avoidance Training Condition | Experimental | The AAT group will push away the joystick from marijuana pictures 90% of the trials and pull towards the marijuana pictures 10% of the trials. Receives: Behavioral: Marijuana Approach Avoidance Training |
| Sham Condition | Sham comparator | The sham group will undergo the same procedures, except the ratio for marijuana pictures will be 50% push and 50% pull. Receives: Behavioral: Marijuana Approach Avoidance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in marijuana use from baseline through end of intervention
Assessing the change in marijuana use (as measured by number of days used marijuana X hits per day) from baseline to end of intervention.
Measured: From 60 days before intervention to end of 3 week intervention
Change in neural reactivity (as measured by BOLD: Blood Oxygen Level-Dependent response) in reward regions during marijuana-cue reactivity task
Assessing the change in neural reactivity to marijuana cues before and after the intervention
Measured: 3 weeks
Change in marijuana approach tendencies (via Approach Avoidance Assessment Task) as measured by reaction times.
Measured: 3 weeks
Change in short-term marijuana use from baseline to 1 month post-intervention
Assessing the short-term effects of intervention on marijuana use (as measured by number of days used marijuana X hits per day) from baseline to 1 month post-intervention.
Measured: From 60 days before intervention to 1 month post-intervention
Secondary outcomes (1)
Change in long-term marijuana use from baseline to 1 year post-treatment
Assessing the long-term effects of intervention on marijuana use (as measured by number of days used marijuana X hits per day) from baseline to 1 year post-intervention.
Measured: From 60 days before intervention to 1 year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Approach/Avoidance TaskStudies 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsay M Squeglia, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723149
- Sponsor's protocol ID
- 44583
- Acronym
- MJ-AAT
- Status last verified
- Sep 2018
- First submitted
- 14 Mar 2016
- Last updated
- 28 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marijuana Approach Bias Retraining and Neural Response in Youth
- ClinicalTrials.gov ID
- NCT02723149
- Acronym / sponsor ID
- MJ-AAT / 44583
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Mar 2016 (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.
This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention reduces cannabis use compared to a control condition containing no active components of AAT. Adolescent heavy MJ users (N=40, ages 16-21) will be randomly assigned to MJ-AAT (n=20) or control condition (MJ-Sham, n=20) for three weeks. The MJ-AAT includes six sessions designed to reduce action tendencies to approach marijuana. The MJ-Sham includes six MJ-AAT-sham conditions. Substance use and cognitive assessment will identify changes in MJ use patterns and mechanisms of treatment outcomes. Additionally, using an functional magnetic resonance imaging marijuana cue reactivity task, we will determine differences in neural response in reward regions before and after 3 weeks of either AAT or sham treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Approach Avoidance Training Condition | Experimental | Behavioral: Marijuana Approach Avoidance TrainingThe AAT group will push away the joystick from marijuana pictures 90% of the trials and pull towards the marijuana pictures 10% of the trials. |
| Sham Condition | Sham comparator | Behavioral: Marijuana Approach Avoidance TrainingThe sham group will undergo the same procedures, except the ratio for marijuana pictures will be 50% push and 50% pull. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- between age 16 and 21
- having >50 lifetime marijuana use episodes and a pattern of at least weekly marijuana use for the past year (>1+/week for 52 weeks) at study entry.
Key exclusion criteria (14 listed)
- not having a parent to consent (for those under age 18)
- prenatal alcohol (>2 drinks on an occasion or >4 drinks in a week) or any tobacco or illicit drug exposure
- premature birth (<34 weeks gestation), birth weight <5 lbs, or other gestational or perinatal complications
- history of a serious medical or neurological problems that could affect blood oxygen level dependent (BOLD) response, brain development, or study participation, including diabetes and recurrent migraine
- current severe Diagnostic and Statistical Manual of Mental Disorders (DSM-5) major Axis I psychiatric disorder (i.e., exclude participants with bipolar disorder, psychotic disorder)
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 |
|---|---|---|
| Marijuana Approach Avoidance TrainingApproach Avoidance Training (AAT) is a novel computerized procedure that modifies implicit approach tendencies by training individuals to selectively avoid drug- related stimuli, thereby overriding habitual approach tendencies. Participants are randomized to either the treatment or sham condition. Treatment duration involves 6 training sessions of approximately 15 minutes each (400 trials). AAT requires minimal training and involves only a computer and a joystick, in which participants are either pulling or pushing the joystick when different marijuana or non-marijuana images are displayed with either yellow (pull) or blue (push) border. | Behavioural | Approach Avoidance Training Condition, Sham Condition |
Primary outcome
Change in marijuana use from baseline through end of intervention
Time frame: From 60 days before intervention to end of 3 week intervention
Assessing the change in marijuana use (as measured by number of days used marijuana X hits per day) from baseline to end of intervention.
Change in neural reactivity (as measured by BOLD: Blood Oxygen Level-Dependent response) in reward regions during marijuana-cue reactivity task
Time frame: 3 weeks
Assessing the change in neural reactivity to marijuana cues before and after the intervention
Change in marijuana approach tendencies (via Approach Avoidance Assessment Task) as measured by reaction times.
Time frame: 3 weeks
Change in short-term marijuana use from baseline to 1 month post-intervention
Time frame: From 60 days before intervention to 1 month post-intervention
Assessing the short-term effects of intervention on marijuana use (as measured by number of days used marijuana X hits per day) from baseline to 1 month post-intervention.
1 secondary outcome
Change in long-term marijuana use from baseline to 1 year post-treatment
Time frame: From 60 days before intervention to 1 year post-intervention
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 28 Sep 2018.
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.
Lindsay M Squeglia, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marijuana Approach Avoidance Training in people with Alcohol Approach/Avoidance Task and Sham Approach/Avoidance Task, 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 2 inclusion and 14 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 28 Sep 2018. 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. Some participants in this study may receive a placebo. 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?
Change in marijuana use from baseline through end of intervention (time frame: From 60 days before intervention to end of 3 week intervention). The study lists 4 primary outcomes in all. 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 28 Sep 2018.