Mood and Decision-making in Methamphetamine Use Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-26

Study Completion Date

2027-07-01

Brief Summary

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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.

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Detailed Description

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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

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Methamphetamine Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

80 participants to be enrolled in the study, with 40 in each arm (randomized arm allocation)

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

At the beginning of the study, the participants and experimenter are blind to the arm allocation. The experimenter's blindness is lifted upon administering the intervention while the participant's blindness is maintained until the end of their participation in the study.

Study Groups

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Positive mood modulation

Use of happy/positive autobiographical memories which are vivid, emotionally pleasurable and not drug-related, as assessed by individual interview and ratings

Group Type ACTIVE_COMPARATOR

Mood modulation

Intervention Type BEHAVIORAL

Autobiographical memory recall designed to modulate mood and affective state by reminiscing about personal life events

Neutral mood modulation

Use of neutral/procedural autobiographical memories which are vivid, emotionally neutral and not drug-related, as assessed by individual interview and ratings

Group Type SHAM_COMPARATOR

Mood modulation

Intervention Type BEHAVIORAL

Autobiographical memory recall designed to modulate mood and affective state by reminiscing about personal life events

Interventions

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Mood modulation

Autobiographical memory recall designed to modulate mood and affective state by reminiscing about personal life events

Intervention Type BEHAVIORAL

Other Intervention Names

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Autobiographical memory recall

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No