Mood and Decision-making in Methamphetamine Use Disorder

NCT06410196 | Recruiting DMC

• 2 other identifiers: 2024-002P20GM121312
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Methamphetamine Abuse

Outcome Measures

Primary Outcomes (5)

• 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)

  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

  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

  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

  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

  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)

  Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1

• Response to punishment in striatum

  Change from pre-intervention (baseline) to post-intervention (30min later) on study day 1

• Influence of abstinence duration on value coding

  Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1

• Influence of craving on value coding

  Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1

• Influence of withdrawal on value coding

  Change from pre-intervention (baseline) to post-intervention (60min later) on study day 1

Study Arms (2)

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

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

Behavioral: Mood modulation

Interventions

Mood modulation BEHAVIORAL

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

Also known as: Autobiographical memory recall

Neutral mood modulation; Positive mood modulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

RECRUITING

Study Officials

• Maelle Gueguen, PhD

  Laureate Institute for Brain Research, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maëlle CM Gueguen, PhD

CONTACT

918-502-5155; mgueguen@laureateinstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 13, 2024
• Study Start: July 26, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

US (1)