STAIR-NT for PTSD and Substance Abuse

Recruiting at 2 trial locations

Overseen By Ana Ventuneac

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: Methadone

Disqualifiers: Cognitive impairment, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for individuals with PTSD (a mental health condition triggered by traumatic events) who also use both cocaine and opioids. The study adapts an existing PTSD treatment, STAIR-NT (Skills Training in Affective and Interpersonal Regulation-Narrative Therapy), to work alongside methadone treatment. Participants will either receive this new treatment or continue with their usual care to determine which is more effective in reducing symptoms. Individuals who have used cocaine and opioids together for 10 or more days in the last month and are currently receiving methadone treatment might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for PTSD and substance use.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must be receiving methadone treatment, it seems you will continue with that medication.

What prior data suggests that the STAIR-NT protocol is safe for individuals with PTSD and substance abuse?

Research has shown that STAIR-NT, a treatment for PTSD and substance abuse, is generally well-tolerated. Studies on PTSD and substance use disorders have found no major safety issues, indicating that participants typically handle the treatment without serious problems. The therapy aids in managing emotions and improving relationships, which can be beneficial for those dealing with PTSD and substance abuse. For those considering joining a trial with STAIR-NT, evidence from past research suggests it is a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STAIR-NT intervention for PTSD and substance abuse because it offers a fresh approach by combining skills training in affect and interpersonal regulation with narrative therapy. Unlike traditional treatments that often focus solely on exposure therapy or medication, STAIR-NT aims to equip individuals with practical skills to manage their emotions and relationships, which can be crucial for those also grappling with substance abuse. This dual focus not only targets the symptoms of PTSD but also addresses some underlying issues that can exacerbate substance use, providing a more holistic and potentially more effective treatment option.

What evidence suggests that STAIR-NT might be an effective treatment for PTSD and substance abuse?

Research has shown that STAIR-NT (Skills Training in Affective and Interpersonal Regulation-Narrative Therapy), which participants in this trial may receive, effectively treats PTSD, particularly in individuals who experienced childhood abuse. Studies have found that STAIR-NT can be as effective as prolonged exposure therapy, a well-known PTSD treatment. This therapy helps individuals manage emotions and improve relationships, which can reduce PTSD symptoms. Although direct evidence of its use in substance abuse situations is limited, the skills taught in STAIR-NT might help individuals with PTSD manage stress that could lead to substance use. Early findings suggest it could be a promising option for those facing both PTSD and substance abuse. ^{5 6 7 8 9}

Who Is on the Research Team?

Amanda Bunting

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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

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.

I am receiving methadone for opioid addiction at the START clinic.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline

Adaptation Phase

Adaptation of the STAIR-NT intervention to a massed treatment schedule within the methadone maintenance treatment program

36 months

Pilot Randomized Control Trial

Testing the adapted STAIR-NT protocol for feasibility, acceptability, and short-term outcomes in a pilot RCT

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• STAIR-NT

Trial Overview

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.

How Is the Trial Designed?

Group I: Adapted STAIR-NT Intervention Experimental Treatment 1 Intervention

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study involving 343 women with co-occurring PTSD and substance use disorders, the integrated treatment Seeking Safety plus treatment as usual (TAU) did not show superior efficacy in reducing PTSD severity compared to TAU alone, but it did improve outcomes related to depression and emotion regulation.

Relapse Prevention Training (RPT) plus TAU was more effective than TAU alone in increasing the number of substance-free days and reducing alcohol severity, indicating that while neither integrated treatment was superior for PTSD, they both offered benefits in other areas of mental health and substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multisite randomized controlled trial of Seeking Safety vs. Relapse Prevention Training for women with co-occurring posttraumatic stress disorder and substance use disorders. Schäfer, I., Lotzin, A., Hiller, P., et al.[2020]

A pilot trial of the Seeking Safety (SS) therapy involving 24 military service members showed significant improvements in PTSD symptoms and substance use, indicating its effectiveness for treating these comorbid conditions.

Participants reported high satisfaction with the SS therapy, suggesting it is a feasible intervention for military personnel dealing with PTSD and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seeking Safety Pilot Outcome Study at Walter Reed National Military Medical Center. Najavits, LM., Lande, RG., Gragnani, C., et al.[2018]

The TIPSS program, which combines cognitive processing therapy for PTSD with cognitive-behavioral therapy for substance use disorders, shows promise in treating individuals with both conditions, as demonstrated in a case study of a woman with PTSD and substance dependence.

This integrated approach effectively reduced both PTSD symptoms and substance use, highlighting its potential as a novel treatment for the common comorbidity of PTSD and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel, Integrated Cognitive-Behavioral Therapy for Co-Occurring Posttraumatic Stress and Substance Use Disorders: A Case Study. Vujanovic, AA., Smith, LJ., Tipton, KP., et al.[2020]

The study involved 34 patients and compared the effectiveness of a combined treatment (Treatment As Usual plus Structured Writing Therapy) for co-morbid PTSD and severe Substance Use Disorder.

While both treatment groups showed a reduction in Substance Use Disorder symptoms, only the combined treatment group (TAU + SWT) demonstrated significant improvements in PTSD severity and remission of PTSD diagnoses, suggesting that adding trauma-focused therapy may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma-focused treatment for posttraumatic stress disorder combined with CBT for severe substance use disorder: a randomized controlled trial. van Dam, D., Ehring, T., Vedel, E., et al.[2021]

Citations

1.

tandfonline.com

tandfonline.com/doi/full/10.1080/20008198.2022.2080933

Full article: Skills Training in Affective and Interpersonal ...

This pilot study examined the feasibility, safety, and outcomes of SNT for CPTSD among women with a history of childhood abuse in a Japanese clinical setting.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11152001/

Enhanced Skills Training in Affective and Interpersonal ...

STAIR-NT was equivalent to an extended (16 sessions) form of prolonged exposure (PE) for DSM-PTSD related to childhood abuse [15]; however, a ...

3.

researchgate.net

researchgate.net/publication/387038488_Skills_Training_in_Affective_and_Interpersonal_Regulation_STAIR_for_Treating_Complex_Trauma_a_Systematic_Review

Skills Training in Affective and Interpersonal Regulation ...

Phase-based treatment versus immediate trauma-focused treatment for post-traumatic stress disorder due to childhood abuse: Randomised clinical ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S088761852300124X

Comparing phase-based treatment, prolonged exposure ...

Psychosis, substance abuse and suicidality were assessed with relevant sections of the MINI neuropsychological interview (Sheehan et al., 1998), and complex ...

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/20008066.2024.2332104

Skills training followed by either EMDR or narrative therapy ...

The aim of phase-based treatment is to tailor treatment to the specific needs to childhood abuse survivors with PTSD with a Skills Training in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11616292/

Study protocol for a randomized controlled trial to adapt ...

Trauma, co-morbid mental health disorders such as PTSD, and polysubstance use complicate treatment outcomes. This study will use eight study ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06307340

Study Details | NCT06307340 | Adaption of the STAIR-NT ...

Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot ...

8.

withpower.com

withpower.com/trial/stair-nt-for-ptsd-and-substance-abuse-45b52

STAIR-NT for PTSD and Substance Abuse

These treatments have been generally well-tolerated, with no major safety concerns reported in trials for PTSD and substance use disorders. Show more.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8782594/

Psychological therapies for post‐traumatic stress disorder and ...

For group‐based therapies, we found that substance use was reduced post‐treatment when participants were offered a full course of 25 sessions of the therapy ' ...