RECRUITING

Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

Quick Facts

Study Start:2024-10-14
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06307340

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * must be 18 years or older,
  2. * be a patient at the START clinic receiving methadone for treatment of opioid use disorder,
  3. * self-report 10+ days of co-use of cocaine and illicit opioids in the past 30-days,
  4. * meet the criteria for stimulant use disorder (cocaine type; mild, moderate or severe) and a score of 3≥ on the PC-PTSD-5.
  1. * cognitive impairment that would interfere with their ability to understand study participation as assessed by the researcher,
  2. * does not speak/understand English at a conversational level,
  3. * plans to leave the START clinic in the next 60 days,
  4. * patients who missed methadone doses (inactive) for 30 days or more, or
  5. * having received clinical care from the interventionist(s) in the past 30 days

Contacts and Locations

Study Contact

Brittany Griffin
CONTACT
646-501-3564
Brittany.Griffin@nyulangone.org
Amanda Bunting
CONTACT
646-501-3563
Amanda.Bunting@nyulangone.org

Principal Investigator

Amanda Bunting
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Amanda Bunting, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-14
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2024-10-14
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Polysubstance Abuse
  • Posttraumatic Stress Disorder