Methamphetamine cue-reactivity and cognitive reappraisal in men with methamphetamine use disorder

Cue Reactivity Modulation in MSM With Methamphetamine Use Disorder

This project will test whether cognitive reappraisal reduces methamphetamine cue-triggered brain and physiological responses during abstinence in men with methamphetamine use disorder and whether effects differ between men who have sex with men (MSM) and non-MSM.

Quick facts

• Study type: Observational
• Enrollment: 88 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Male
• Sponsor: Icahn School of Medicine at Mount Sinai (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07086014 on ClinicalTrials.gov

What this trial studies

In a two-year observational cohort at the Mount Sinai Addiction Institute, researchers will record psychophysiological responses (including EEG, focusing on the LPP) and craving to methamphetamine-related cues and follow participants across specified abstinence windows. Men aged 18–60 with DSM-5 methamphetamine use disorder who identify as MSM or non-MSM will be enrolled and stratified by current versus abstinent status to examine incubation of cue-reactivity over time. Cognitive reappraisal use and training will be measured to see if reductions in cue-elicited EEG and craving accompany regulation, and associations with clinical outcomes will be tracked. The study will compare group differences between MSM and non-MSM to determine whether biomarkers or reappraisal effects vary by sexual orientation.

Who should consider this trial

Good fit: Ideal candidates are males aged 18–60 with a DSM-5 diagnosis of methamphetamine use disorder who identify as MSM or non-MSM and meet the study's abstinence windows (about 1–3 weeks for current users or ~2–4 months for abstinent participants).

Not a fit: Women, people outside the 18–60 age range, individuals whose primary drug is not methamphetamine, and those unable to meet required abstinence or in-person visit requirements are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the study could identify a measurable brain-based marker of methamphetamine craving and show that cognitive reappraisal lowers cue-reactivity, informing targeted relapse-prevention strategies for men with MUD.

How similar studies have performed: Previous work in cocaine use disorder and smoking has shown that cognitive reappraisal can reduce cue-reactivity and craving and preliminary EEG studies have demonstrated LPP reductions, but applying these measures specifically to methamphetamine use and to MSM versus non-MSM comparisons is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Ability to understand and give informed consent
* Identify as either MSM or non-MSM
* Males; Age 18-60
* DSM-5 Diagnosis of MUD (Methamphetamine Use Disorder)
* Have appropriate abstinence duration \[i.e., current Methamphetamine users (MA): 2 weeks (range: 1-3 weeks); MA-abstinent: 3 months (range: 2-4 months)\]
* Treatment-seeking MUD must be in a treatment facility for substance use disorder, with MA as the primary drug (at the first visit)
* Treatment-seeking MUD must be abstinent from MA use for approximately 2 weeks (range: 1-3 weeks) at enrollment.

Exclusion Criteria:

• Women

Where this trial is running

New York, New York

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Muhammad A Parvaz, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Muhammad A Parvaz

Conditions: Methamphetamine Use Disorder, methamphetamine, cue-reactivity, craving, EEG, incubation, cognitive reappraisal