Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for individuals in New York City who are undergoing methadone maintenance treatment and also use stimulants and opioids. Participants should have PTSD and be willing to try a new therapy schedule. The study excludes those not meeting these specific conditions or unable to follow the trial protocol.Inclusion Criteria
I am 18 years old or older.
Self-report 10+ days of co-use of cocaine and illicit opioids in the past 30 days
Meet the criteria for stimulant use disorder (cocaine type; mild, moderate or severe) and a score of 3≥ on the PC-PTSD-5.
+1 more
Exclusion Criteria
Patients who missed methadone doses (inactive) for 30 days or more
Does not speak/understand English at a conversational level
Plans to leave the START clinic in the next 60 days
+2 more
Participant Groups
The trial tests an adapted version of STAIR-NT, a PTSD intervention, integrated into a methadone program for people with polysubstance use. It compares the effectiveness of this new approach against the usual treatment methods over several months.
2Treatment groups
Experimental Treatment
Active Control
Group I: Adapted STAIR-NT InterventionExperimental Treatment1 Intervention
Group II: Treatment as Usual (TAU)Active Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Florida State UniversityTallahassee, FL
START Treatment and Recovery CentersBrooklyn, NY
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator