Methamphetamine Cue-reactivity
ConditionMethamphetamine Use Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-60
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial 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".
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Cognitive Reappraisal
Behavioralan emotion-regulation strategy while being asked to complete cognitive tasks.
Treatment groups
88 Participants
are divided into 4 treatment groupsGroup A: MSM - MUD (Current)1 intervention
Group B: MSM - MUD (Abstinent)1 intervention
Group C: non-MSM - MUD (Current)1 intervention
Group D: non-MSM - SUD (Abstinent)1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
at approx. 2 weeks and 3 months abstinenceSponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov