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NCT Number: NCT07086014

Methamphetamine Cue-reactivity

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.

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Key information

Conditions

Methamphetamine Use Disorder

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location status: Recruiting

Location contact

Muhammad A Parvaz

PRINCIPAL_INVESTIGATOR

Muhammad A Parvaz, PhD

CONTACT

[email protected]

212-241-3638

About this study

Cognitive Reappraisal (CR) is an extensively characterized emotion-regulation strategy that impacts early cognitive stages of emotion-generative processes and can be used to regulate emotional experience and expression. CR techniques include "distancing" that aims at changing the emotional impact of a situation by taking the perspective of a detached observer, and "reinterpretation" that focuses on re-evaluating the emotional situation in unemotional terms. Neuroimaging studies of CR implicate the engagement of regions that have typically been associated with conflict monitoring, selective attention, and regulation of negative affect. A growing literature indicates that CR can attenuate heightened cue-reactivity in addicted individuals. The researchers preliminary data in CUD are consonant with this view and show that decrease in cue-reactivity can be quantified by a reduction in the LPP (Parvaz et al., PNAS, 2021). The researchers have also shown that more frequent use of CR is correlated with reduced cue-reactivity and lower craving in CUD. Others have reported that CR can modulate attention bias to affective stimuli with sustained decrease even after regulation demands are lifted. Clinical studies show that CR training is associated with better cognitive control, and better clinical outcomes in smokers. Thus, CR has the potential to decrease MA cue-reactivity and may lead to better clinical outcomes in MSM with MUD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive reappraisal

Behavioral

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

Primary outcomes

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

    Time frame: at approx. 2 weeks and 3 months abstinence

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad A Parvaz

CONTACT

[email protected]

212-241-3638

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Cue Reactivity Modulation in MSM With Methamphetamine Use Disorder

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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