Methamphetamine AbuseMDM-MUDNCT06410196
Mood and Decision-making in Methamphetamine Use Disorder
A study testing Mood modulation in people with Methamphetamine Abuse, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Methamphetamine Abuse
- What is being tested?
- Mood modulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2024to 23 Mar 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
Official title: Modulating Explore-exploit Biases by Improving Mood in Adults With Methamphetamine Use Disorder
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.
Read the detailed description
The growing epidemic of methamphetamine use disorder (MUD) is a significant burden on public health with surging overdose deaths, high likelihood of relapse, and current lack of approved medication to treat the disorder. When it comes to decision-making, individuals with MUD often prioritize drug over non-drug rewards despite negative life consequences; in addition, they may not sufficiently "explore" all available choices to "exploit" the best one (in other words, make the optimal choice leading to positive consequences). Therefore, the "explore-exploit" trade-off is often dysfunctional in MUD. Decision-making imbalances in the explore-exploit trade-off may extend well into abstinence, a period marked by a negative affective state (low mood, high depression and anxiety, withdrawal), which in turn triggers heightened craving and subsequent drug use urges. The insula, anterior cingulate cortex and striatum are crucial brain regions involved in explore-exploit behaviors and affective state signaling that have also been linked to drug reward processing in MUD. We propose that reducing negative affective state (improving mood) could help normalize explore-exploit behaviors and the response of these brain areas in individuals currently abstinent from methamphetamine and other drugs. This project will use a non-drug-related autobiographical memory recall to improve the mood of individuals with MUD and measure whether it normalizes non-drug decision-making, using a functional magnetic resonance imaging-based 3-arm bandit task and a behavioral contextual reinforcement learning task. A mixed experimental design in n=80 (72 completers, assuming 10% attrition) allows the identification of a between-subjects effect of positive (n=40, 36 completers) vs. neutral (n=40, 36 completers) mood modulation and assess the within-subject impact on explore-exploit behaviors pre- versus post-mood modulation. Mood groups will be compared on positive and negative affect, and behavioral/brain responses to reward valuation, outcomes and learning rates.
The overarching goal is to establish that improving mood in individuals with MUD can reduce their negative affective state, normalize outcome sensitivity in key brain regions and associated learning, and reduce the influence of drug rewards on the valuation of non-drug rewards. This approach of this proposal embodies the goals of the NIH RDoC Initiative and the NeuroMAP Center by identifying an actionable disease-modifying target (mood) and studying its effect on the cognitive and neural dysfunction underlying a specific cognitive process (explore-exploit behaviors) relevant to MUD, and possibly other related neuropsychiatric disorders. By targeting the intertwined mechanisms between negative affect and explore-exploit biases, innovative, effective intervention strategies for MUD may be unveiled, addressing a critical public health challenge.
- Conditions
- Methamphetamine Abuse
- Being tested
- Mood modulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mood modulationBehavioural
Also called Autobiographical memory recall
Autobiographical memory recall designed to modulate mood and affective state by reminiscing about personal life events
| Study group | Role | What they receive |
|---|---|---|
| Positive mood modulation | Active comparator | Use of happy/positive autobiographical memories which are vivid, emotionally pleasurable and not drug-related, as assessed by individual interview and ratings Receives: Behavioral: Mood modulation |
| Neutral mood modulation | Sham comparator | Use of neutral/procedural autobiographical memories which are vivid, emotionally neutral and not drug-related, as assessed by individual interview and ratings Receives: Behavioral: Mood modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current affective state
Use of PANAS-PA and PANAS-NA questionnaires to measure positive and negative affect respectively (scale range: 0=low; 60=high; low mood is defined as low positive and/or high negative affect)
Measured: Change from pre-intervention (baseline) to post-intervention (90min later) on study day 1
Learning rates
Computational modeling is used to compute how fast (learning rate) participants update their choice strategy following appetitive and aversive outcomes during 3-arm bandit task
Measured: Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1
Response to punishment in insular cortex
BOLD signal is used to measure the activity in the insula as a predefined region of interest (ROI), using Brainnetome atlas, following the delivery of aversive outcomes during 3-arm bandit task
Measured: Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1
Correct choice rate of mid-value option in contexts 1 (M1) and 2 (M2) during the testing phase
Proportion of trials for which the mid-value option is correctly chosen when paired against a high- or low-value option during contextual RL task
Measured: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
∆BIC for absolute vs. relative value coding
Difference in model-fitting between the absolute and intrinsically enhanced or range adaptive (relative) models as measured by Bayesian Information Criterion (∆BIC) during contextual RL task
Measured: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
Secondary outcomes (5)
Response to punishment in anterior cingulate cortex (ACC)
BOLD signal is used to measure the activity in the ACC as a predefined ROI, using Brainnetome atlas, following the delivery of aversive outcomes during 3-arm bandit task
Measured: Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1
Response to punishment in striatum
BOLD signal is used to measure the activity in the striatum as a predefined ROI, using Brainnetome atlas, following the delivery of aversive outcomes during 3-arm bandit task
Measured: Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1
Influence of abstinence duration on value coding
Across participants, correlation of number of days since last use of amphetamine with ∆BIC during contextual RL task
Measured: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
Influence of craving on value coding
Across participants, correlation of intensity of craving for amphetamine with ∆BIC during contextual RL task
Measured: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
Influence of withdrawal on value coding
Across participants, correlation of intensity of withdrawal for amphetamine with ∆BIC during contextual RL task
Measured: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start26 Jul 2024
- Primary completion23 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 80 participants to be enrolled in the study, with 40 in each arm (randomized arm allocation)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Maelle Gueguen, PhD, Principal investigator, Laureate Institute for Brain Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410196
- Sponsor's protocol ID
- 2024-002
- Other IDs
- P20GM121312
- Acronym
- MDM-MUD
- Status last verified
- Jun 2026
- First submitted
- 3 May 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Explore-exploit Biases by Improving Mood in Adults With Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT06410196
- Acronym / sponsor ID
- MDM-MUD / 2024-002
- Conditions
- Methamphetamine Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 13 May 2024 (actual)
- 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.
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.
Detailed description
The growing epidemic of methamphetamine use disorder (MUD) is a significant burden on public health with surging overdose deaths, high likelihood of relapse, and current lack of approved medication to treat the disorder. When it comes to decision-making, individuals with MUD often prioritize drug over non-drug rewards despite negative life consequences; in addition, they may not sufficiently "explore" all available choices to "exploit" the best one (in other words, make the optimal choice leading to positive consequences). Therefore, the "explore-exploit" trade-off is often dysfunctional in MUD. Decision-making imbalances in the explore-exploit trade-off may extend well into abstinence, a period marked by a negative affective state (low mood, high depression and anxiety, withdrawal), which in turn triggers heightened craving and subsequent drug use urges. The insula, anterior cingulate cortex and striatum are crucial brain regions involved in explore-exploit behaviors and affective state signaling that have also been linked to drug reward processing in MUD. We propose that reducing negative affective state (improving mood) could help normalize explore-exploit behaviors and the response of these brain areas in individuals currently abstinent from methamphetamine and other drugs. This project will use a non-drug-related autobiographical memory recall to improve the mood of individuals with MUD and measure whether it normalizes non-drug decision-making, using a functional magnetic resonance imaging-based 3-arm bandit task and a behavioral contextual reinforcement learning task. A mixed experimental design in n=80 (72 completers, assuming 10% attrition) allows the identification of a between-subjects effect of positive (n=40, 36 completers) vs. neutral (n=40, 36 completers) mood modulation and assess the within-subject impact on explore-exploit behaviors pre- versus post-mood modulation. Mood groups will be compared on positive and negative affect, and behavioral/brain responses to reward valuation, outcomes and learning rates.
The overarching goal is to establish that improving mood in individuals with MUD can reduce their negative affective state, normalize outcome sensitivity in key brain regions and associated learning, and reduce the influence of drug rewards on the valuation of non-drug rewards. This approach of this proposal embodies the goals of the NIH RDoC Initiative and the NeuroMAP Center by identifying an actionable disease-modifying target (mood) and studying its effect on the cognitive and neural dysfunction underlying a specific cognitive process (explore-exploit behaviors) relevant to MUD, and possibly other related neuropsychiatric disorders. By targeting the intertwined mechanisms between negative affect and explore-exploit biases, innovative, effective intervention strategies for MUD may be unveiled, addressing a critical public health challenge.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 80 participants to be enrolled in the study, with 40 in each arm (randomized arm allocation)
| Arm | Type | Receives |
|---|---|---|
| Positive mood modulation | Active comparator | Behavioral: Mood modulationUse of happy/positive autobiographical memories which are vivid, emotionally pleasurable and not drug-related, as assessed by individual interview and ratings |
| Neutral mood modulation | Sham comparator | Behavioral: Mood modulationUse of neutral/procedural autobiographical memories which are vivid, emotionally neutral and not drug-related, as assessed by individual interview and ratings |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Mood modulationAlso: Autobiographical memory recallAutobiographical memory recall designed to modulate mood and affective state by reminiscing about personal life events | Behavioural | Neutral mood modulation, Positive mood modulation |
Primary outcome
Current affective state
Time frame: Change from pre-intervention (baseline) to post-intervention (90min later) on study day 1
Use of PANAS-PA and PANAS-NA questionnaires to measure positive and negative affect respectively (scale range: 0=low; 60=high; low mood is defined as low positive and/or high negative affect)
Learning rates
Time frame: Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1
Computational modeling is used to compute how fast (learning rate) participants update their choice strategy following appetitive and aversive outcomes during 3-arm bandit task
Response to punishment in insular cortex
Time frame: Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1
BOLD signal is used to measure the activity in the insula as a predefined region of interest (ROI), using Brainnetome atlas, following the delivery of aversive outcomes during 3-arm bandit task
Correct choice rate of mid-value option in contexts 1 (M1) and 2 (M2) during the testing phase
Time frame: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
Proportion of trials for which the mid-value option is correctly chosen when paired against a high- or low-value option during contextual RL task
∆BIC for absolute vs. relative value coding
Time frame: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
Difference in model-fitting between the absolute and intrinsically enhanced or range adaptive (relative) models as measured by Bayesian Information Criterion (∆BIC) during contextual RL task
5 secondary outcomes
Response to punishment in anterior cingulate cortex (ACC)
Time frame: Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1
Response to punishment in striatum
Time frame: Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1
Influence of abstinence duration on value coding
Time frame: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
Influence of craving on value coding
Time frame: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
Influence of withdrawal on value coding
Time frame: Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1
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 16 Jun 2026.
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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.
Maelle Gueguen, PhD principal investigator
Laureate Institute for Brain Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mood modulation in people with Methamphetamine Abuse, run by Laureate Institute for Brain Research, Inc. 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 4 inclusion and 7 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 16 Jun 2026. 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?
Current affective state (time frame: Change from pre-intervention (baseline) to post-intervention (90min later) on study day 1). The study lists 5 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 16 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.