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Methamphetamine Cue-reactivity

Cue Reactivity Modulation in MSM With Methamphetamine Use Disorder

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07086014
Enrollment
88
Registered
2025-07-25
Start date
2024-08-19
Completion date
2025-08-30
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methamphetamine Use Disorder

Keywords

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

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.

Detailed description

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.

Interventions

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

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in EEG-derived late positive potential (LPP) Amplitudeat approx. 2 weeks and 3 months abstinenceChange 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.

Countries

United States

Contacts

Primary ContactMuhammad A Parvaz
muhammad.parvaz@mssm.edu212-241-3638

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026