Methamphetamine Cue-reactivity

NCT07086014 | Recruiting

• 2 other identifiers: STUDY-20-00284R61DA056779
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

In this observational cohort study, the researchers propose to first identify a psychophysiological marker of methamphetamine cue-reactivity and its incubation with abstinence from methamphetamine use (MUD) and examine group-differences between men who have sex with men (MSM) and non-MSM MUD. The primary objective is to identify psychophysiological markers of methamphetamine (MA) cue-reactivity and its abstinence incubation. The secondary objective is to examine group-differences in methamphetamine use disorder (MUD) individuals between homosexual men (MSM) and heterosexual men (non-MSM). The primary endpoint is to assess incubation of cue-reactivity longitudinally with its reduction in cognitive reappraisal, and the secondary endpoint is to examine the impact of cognitive reappraisal on clinical outcomes of methamphetamine use disorder (MUD) in homosexual men (MSM). 2-year long study. Screening and enrollment will be done at different locations of the Addiction Institute of Mount Sinai. The EEG session will be done at Icahn School of Medicine at Mount Sinai. Participation in the research study will be for a single EEG session.

Conditions

Methamphetamine Use Disorder

Keywords

methamphetamine; cue-reactivity; craving; EEG; incubation; cognitive reappraisal

Outcome Measures

Primary Outcomes (1)

• Change in EEG-derived late positive potential (LPP) Amplitude

  Change in amplitude (or incubation of) the EEG-derived late positive potential (LPP) - an objective neurophysiological marker of drug cue-reactivity - occurs 400 msec after the onset of a drug-related cue. The LPP amplitude has also shown to predict self-reported craving, simulated drug-seeking behavior and relapse, highlighting the clinical utility of this objective metric of cue-reactivity.

  at approx. 2 weeks and 3 months abstinence

Study Arms (4)

MSM - MUD (Current)

Participants who are MSM and are currently using methamphetamine (MA abstinence: 2 weeks; range: 1-3 weeks).

Behavioral: Cognitive Reappraisal

MSM - MUD (Abstinent)

Participants who are MSM and are abstaining from using methamphetamine (MA abstinence: 3 months; range: 2-4 months).

Behavioral: Cognitive Reappraisal

non-MSM - MUD (Current)

Participants who are not MSM and are currently using methamphetamine (MA abstinence: 2 weeks; range: 1-3 weeks).

Behavioral: Cognitive Reappraisal

non-MSM - SUD (Abstinent)

Participants who are not MSM and are abstaining from using methamphetamine (MA abstinence: 3 months; range: 2-4 months).

Behavioral: Cognitive Reappraisal

Interventions

Cognitive Reappraisal BEHAVIORAL

an emotion-regulation strategy while being asked to complete cognitive tasks.

MSM - MUD (Abstinent); MSM - MUD (Current); non-MSM - MUD (Current); non-MSM - SUD (Abstinent)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: This is a study on MSM and non-MSM males only, who have shown to be at a high risk for methamphetamine use disorder.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

44 current MA-using (MA abstinence: 2 weeks; range: 1-3 weeks), and 44 MA-abstinent (MA abstinence: 3 months; range: 2-4 months), individuals with MUD. Importantly, 50% in each group will be MSM, and the other 50% will be non-MSM men, resulting in 4 groups: (1) MSM/current MA, (2) MSM/abstinent, (3) non-MSM/current MA, and (4) non-MSM/abstinent; n=22 per group, matched on age and HIV status. Men who identify as "homosexual/gay" or "bisexual" and/or report having had sex with a man in the last 12 months will be defined as "MSM" and those who identify as "heterosexual/straight" and do not report having sex with men in the last 12 months as "non-MSM".

You may qualify if:

• 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.

You may not qualify if:

• Women

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Study Officials

• Muhammad A Parvaz, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad A Parvaz

CONTACT

212-241-3638; muhammad.parvaz@mssm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: August 19, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Data are available indefinitely at (Link to be included in the URL field below).

Locations

US (1)