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Methamphetamine Cue-reactivity

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Mount Sinai Health System

Status

Enrolling

Conditions

Methamphetamine Use Disorder

Treatments

Behavioral: Cognitive Reappraisal

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT07086014
R61DA056779 (U.S. NIH Grant/Contract)
STUDY-20-00284

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

88 participants in 4 patient groups

MSM - MUD (Current)
Description:
Participants who are MSM and are currently using methamphetamine (MA abstinence: 2 weeks; range: 1-3 weeks).
Treatment:
Behavioral: Cognitive Reappraisal
MSM - MUD (Abstinent)
Description:
Participants who are MSM and are abstaining from using methamphetamine (MA abstinence: 3 months; range: 2-4 months).
Treatment:
Behavioral: Cognitive Reappraisal
non-MSM - MUD (Current)
Description:
Participants who are not MSM and are currently using methamphetamine (MA abstinence: 2 weeks; range: 1-3 weeks).
Treatment:
Behavioral: Cognitive Reappraisal
non-MSM - SUD (Abstinent)
Description:
Participants who are not MSM and are abstaining from using methamphetamine (MA abstinence: 3 months; range: 2-4 months).
Treatment:
Behavioral: Cognitive Reappraisal

Trial contacts and locations

1

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Central trial contact

Muhammad A Parvaz

Data sourced from clinicaltrials.gov

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