NCT06307340|Active Not RecruitingDMC
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Sponsor study identifier
interventional
76
1 country
3
Study Start
October 14, 2024
Actual (reported)Primary Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 6, 2024
Actual (reported)March 12, 2024
Actual (reported)October 14, 2024
Actual (reported)June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Proportion of Eligible Participants
Proportion of persons eligible to enroll in the study of all possible MMT patients approached. Assessed using count data of individuals failing screen.
Baseline
Proportion of Eligible Participants who Enroll
.Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.
Baseline
Number of Intervention Sessions Completed
Up to Month 3
Clinician-Rated Feasibility of Intervention Measure (FIM) Score
4-item, clinician-rated assessment of the feasibility of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated feasibility.
Month 3
Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score
4-item, clinician-rated assessment of the acceptability of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated acceptability.
Adapted version of evidence-based behavioral PTSD intervention.
Treatment as usual.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Florida State University
Tallahassee, Florida, 32306, United States
START Treatment and Recovery Centers
Brooklyn, New York, 11238, United States
NYU Langone Health
New York, New York, 10016, United States
Renn T, Griffin B, Kumaravelu V, Ventuneac A, Santacatterina M, Bunting AM. Study protocol for a randomized controlled trial to adapt a posttraumatic stress disorder intervention of patients with opioid-stimulant polysubstance use receiving methadone maintenance treatment. BMC Psychiatry. 2024 Dec 4;24(1):879. doi: 10.1186/s12888-024-06348-0.
Amanda Bunting
NYU Langone Health
76 participants (actual enrollment reported by the registry).
First Submitted
March 6, 2024
First Posted
March 12, 2024
Study Start
October 14, 2024
Actual (reported)Improving Function Through Primary Care Treatment of Posttraumatic Stress Disorder (PTSD)
Month 3
Number of Days of Co-Use of Cocaine and Illicit Opioids
Measured using the Addiction Severity Index (ASI) questionnaire.
Month 3
Number of Substances Used based on ASI Self-Report
Measured using the Addiction Severity Index (ASI) questionnaire, a self-report assessment to gauge the severity of a person's substance abuse.
Month 3
Number of Substances Used based on Urine Drug Screen
Month 3
Number of Substances Used based on Chart Abstraction of Toxicology Results
Month 3
PTSD Checklist for DSM-5 (PCL-5) Score
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Each item is rated on a scale from 0-4. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; higher scores indicate greater severity of PTSD.
Month 3
Negative Mood Regulation Scale Score
30-item assessment of individuals' beliefs and expectations regarding their ability to regulate their negative mood and emotions. Each item is rated on a 5-point Likert scale ranging from 1 (not at all effective) to 5 (extremely effective). The total score ranges from 30-150; higher scores indicate more effective negative mood regulation.
Month 3
Inventory of Interpersonal Problems Score
A 127-item, self-report inventory that asks participants to rate a variety of interpersonal problems that may cause distress. The items are divided into two groups: (1) interpersonal inadequacies or inhibitions (78 items), (2) excesses or compulsions (49 items). Participants rate each item on a scale from 0 to 4 on how much difficulty/distress they feel regarding the item. The total score is calculated by adding the item responses; lower scores indicate less difficulty/distress.
Month 3
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 12, 2026
Record last verified: 2026-03
Deidentified quantitative assessment data will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. Data will be stored in a data repository. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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