Methamphetamine Cue-reactivity

NCT ID: NCT07086014

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-19

Study Completion Date

2025-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Methamphetamine Use Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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MSM - MUD (Current)

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

Cognitive Reappraisal

Intervention Type BEHAVIORAL

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

MSM - MUD (Abstinent)

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

Cognitive Reappraisal

Intervention Type BEHAVIORAL

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

non-MSM - MUD (Current)

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

Cognitive Reappraisal

Intervention Type BEHAVIORAL

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

non-MSM - SUD (Abstinent)

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

Cognitive Reappraisal

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive Reappraisal

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Parvaz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad A Parvaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Muhammad A Parvaz

Role: CONTACT

212-241-3638

Facility Contacts

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Muhammad A Parvaz, PhD

Role: primary

212-241-3638

Other Identifiers

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R61DA056779

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY-20-00284

Identifier Type: -

Identifier Source: org_study_id

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