Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07086014

Conditions

Methamphetamine Use Disorder

Eligibility Criteria

Sex: Male

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Cognitive Reappraisal

Study Details

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

Study ID

NCT07086014

Start date

Aug 19, 2024

Status verified date

Jul, 2025

Completion date

Aug 30, 2025

Anticipated

Primary completion date

Aug 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

88 participants

Anticipated

Interventions and Outcome Measures

Arms

MSM - MUD (Current)

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

MSM - MUD (Abstinent)

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

non-MSM - MUD (Current)

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

non-MSM - SUD (Abstinent)

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

Interventions

Cognitive Reappraisal

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

Primary outcome measure

  • Change in EEG-derived late positive potential (LPP) Amplitude [ Time Frame: at approx. 2 weeks and 3 months abstinence ]

Central Contacts and Locations

Central contacts

Muhammad A Parvaz

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

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Muhammad A Parvaz, PhD

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

Principal Investigator:

Muhammad A Parvaz

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 25, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-07-25.