Mood and Decision-making in Methamphetamine Use Disorder (NCT06410196) | Clinical Trial Compass
CompletedNot Applicable
Mood and Decision-making in Methamphetamine Use Disorder
United States80 participantsStarted 2024-07-26
Plain-language summary
In this project, the investigators examine behavior and associated brain activity during explore-exploit decision-making tasks performed pre- and post-modulation of affective state using autobiographical memory recall. The investigators hypothesize that a positive memory recall will reduce negative affective state, reduce explore-exploit biases and normalize the associated brain activity. The investigators propose a randomized double-blind, sham-controlled trial of positive autobiographical memory recall with 80 adults (n=40 per arm) with methamphetamine use disorder (MUD) currently involved in abstinence only treatment centers.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults 18-65 years old
* English proficiency as evaluated by language ability during screening
* Past-year diagnosis of DSM-5 methamphetamine use disorder (MUD) confirmed by the MINI
* Actively enrolled in treatment for substance use disorder.
Exclusion Criteria:
* Severe traumatic brain injury (as indicated by a score ≥3 on the Tulsa Head Injury Screen
* Any medical condition interfering with the participation in the study as determined by medical screening
* DSM-5 diagnosis of psychotic disorders, bipolar I disorder, or major depressive disorder with psychosis
* fMRI contraindications as listed on the MR environment screening form
* Positive breathalyzer for alcohol
* Positive urine drug screening, except for cannabis or prescribed benzodiazepines, as indicated in the medical screening
* Evidence of inability to comply with study procedures based on judgement of the experimenter.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Current affective state
Timeframe: Change from pre-intervention (baseline) to post-intervention (90min later) on study day 1
2
Learning rates
Timeframe: Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1
3
Response to punishment in insular cortex
Timeframe: Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1
4
Correct choice rate of mid-value option in contexts 1 (M1) and 2 (M2) during the testing phase
Timeframe: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
5
∆BIC for absolute vs. relative value coding
Timeframe: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
Trial details
NCT IDNCT06410196
SponsorLaureate Institute for Brain Research, Inc.