Methamphetamine Use DisorderNCT07086014
Methamphetamine Cue-reactivity
An observational study of Methamphetamine Use Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Cognitive Reappraisal
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 30 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: 44 current MA-using (MA abstinence: 2 weeks; range: 1-3 weeks), and 44 MA-abstinent (MA abstinence: 3 months; range: 2-4 months), individuals with MUD. Importantly, 50% in each group will be MSM, and the other 50% will be non-MSM men, resulting in 4 groups: (1) MSM/current MA, (2) MSM/abstinent, (3) non-MSM/current MA, and (4) non-MSM/abstinent; n=22 per group, matched on age and HIV status. Men who identify as "homosexual/gay" or "bisexual" and/or report having had sex with a man in the last 12 months will be defined as "MSM" and those who identify as "heterosexual/straight" and do not report having sex with men in the last 12 months as "non-MSM".
Who may be able to join
- 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.
Who cannot join
- Women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Muhammad A Parvaz, PhD, 212-241-3638, muhammad.parvaz@mssm.edu
Muhammad A Parvaz
About this study
Official title: Cue Reactivity Modulation in MSM With Methamphetamine Use Disorder
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.
Read the 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.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Cognitive Reappraisal
- Keywords
- methamphetamine, cue-reactivity, craving, EEG, incubation, cognitive reappraisal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive ReappraisalBehavioural
an emotion-regulation strategy while being asked to complete cognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| MSM - MUD (Current) | Participants who are MSM and are currently using methamphetamine (MA abstinence: 2 weeks; range: 1-3 weeks). Receives: Behavioral: Cognitive Reappraisal | |
| MSM - MUD (Abstinent) | Participants who are MSM and are abstaining from using methamphetamine (MA abstinence: 3 months; range: 2-4 months). Receives: Behavioral: Cognitive Reappraisal | |
| non-MSM - MUD (Current) | Participants who are not MSM and are currently using methamphetamine (MA abstinence: 2 weeks; range: 1-3 weeks). Receives: Behavioral: Cognitive Reappraisal | |
| non-MSM - SUD (Abstinent) | Participants who are not MSM and are abstaining from using methamphetamine (MA abstinence: 3 months; range: 2-4 months). Receives: Behavioral: Cognitive Reappraisal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EEG-derived late positive potential (LPP) Amplitude
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.
Measured: at approx. 2 weeks and 3 months abstinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start19 Aug 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Muhammad Parvaz, Icahn School of Medicine at Mount Sinai
- Investigators
- Muhammad A Parvaz, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086014
- Sponsor's protocol ID
- STUDY-20-00284
- Other IDs
- R61DA056779
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cue Reactivity Modulation in MSM With Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT07086014
- Acronym / sponsor ID
- STUDY-20-00284
- Conditions
- Methamphetamine Use Disorder
- Keywords
- methamphetamine, cue-reactivity, craving, EEG, incubation, cognitive reappraisal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MSM - MUD (Current) | – | Behavioral: Cognitive ReappraisalParticipants who are MSM and are currently using methamphetamine (MA abstinence: 2 weeks; range: 1-3 weeks). |
| MSM - MUD (Abstinent) | – | Behavioral: Cognitive ReappraisalParticipants who are MSM and are abstaining from using methamphetamine (MA abstinence: 3 months; range: 2-4 months). |
| non-MSM - MUD (Current) | – | Behavioral: Cognitive ReappraisalParticipants who are not MSM and are currently using methamphetamine (MA abstinence: 2 weeks; range: 1-3 weeks). |
| non-MSM - SUD (Abstinent) | – | Behavioral: Cognitive ReappraisalParticipants who are not MSM and are abstaining from using methamphetamine (MA abstinence: 3 months; range: 2-4 months). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 44 current MA-using (MA abstinence: 2 weeks; range: 1-3 weeks), and 44 MA-abstinent (MA abstinence: 3 months; range: 2-4 months), individuals with MUD. Importantly, 50% in each group will be MSM, and the other 50% will be non-MSM men, resulting in 4 groups: (1) MSM/current MA, (2) MSM/abstinent, (3) non-MSM/current MA, and (4) non-MSM/abstinent; n=22 per group, matched on age and HIV status. Men who identify as "homosexual/gay" or "bisexual" and/or report having had sex with a man in the last 12 months will be defined as "MSM" and those who identify as "heterosexual/straight" and do not report having sex with men in the last 12 months as "non-MSM".
Key inclusion criteria (7 listed)
- 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)]
Key exclusion criteria (1 listed)
- Women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Reappraisalan emotion-regulation strategy while being asked to complete cognitive tasks. | Behavioural | MSM - MUD (Abstinent), MSM - MUD (Current), non-MSM - MUD (Current), non-MSM - SUD (Abstinent) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad A Parvaz, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methamphetamine Use Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad A Parvaz (212-241-3638, muhammad.parvaz@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EEG-derived late positive potential (LPP) Amplitude (time frame: at approx. 2 weeks and 3 months abstinence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.