| NCT ID | NCT07086014 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Methamphetamine Use Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 88 participants |
| Start Date | 2024-08-19 |
| Primary Completion | 2025-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 88 participants in total. It began in 2024-08-19 with a primary completion date of 2025-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Muhammad A Parvaz, PhD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT07086014 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 60 Years, studying Methamphetamine Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07086014 currently recruiting?
Yes, NCT07086014 is actively recruiting participants. Contact the research team at muhammad.parvaz@mssm.edu for enrollment information.
Where is the NCT07086014 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07086014 clinical trial?
NCT07086014 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Muhammad A Parvaz, PhD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 88 participants.