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

Trial Summary

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 data supports the effectiveness of the treatment STAIR-NT for PTSD and Substance Abuse?

While there is no direct data on STAIR-NT, similar integrated cognitive-behavioral therapies like TIPSS and SDPT have shown promise in reducing PTSD symptoms and substance use. These treatments combine elements like cognitive processing therapy and relapse prevention, which have been effective in other studies. ^{1 2 3 4 5}

Is STAIR-NT safe for treating PTSD and substance abuse?

The safety of treatments similar to STAIR-NT, like Seeking Safety and COPE, has been evaluated in studies. These treatments have been generally well-tolerated, with no major safety concerns reported in trials for PTSD and substance use disorders. ^{2 3 6 7 8}

How is the STAIR-NT treatment for PTSD and substance abuse different from other treatments?

STAIR-NT is unique because it integrates cognitive-behavioral therapy techniques specifically designed to address both PTSD and substance use disorders together, which is not commonly found in standard treatments. This approach aims to simultaneously reduce PTSD symptoms and substance use, offering a more comprehensive solution for individuals with both conditions. ^{1 2 4 9 10}

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.

Research Team

Amanda Bunting

Principal Investigator

NYU Langone Health

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Novel, Integrated Cognitive-Behavioral Therapy for Co-Occurring Posttraumatic Stress and Substance Use Disorders: A Case Study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Substance dependence posttraumatic stress disorder therapy. An integrated cognitive-behavioral approach. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Trauma-focused treatment for posttraumatic stress disorder combined with CBT for severe substance use disorder: a randomized controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of psychological interventions for comorbid post-traumatic stress disorder and substance use disorder. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Seeking Safety Pilot Outcome Study at Walter Reed National Military Medical Center. [2018]

6. United States 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of trauma-focused and non-trauma-focused psychotherapy for PTSD among veterans with comorbid substance use disorders: Protocol & rationale for a randomized clinical trial. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE): A Pilot Study in Alcohol-dependent Women. [2019]

9. England pubmed.ncbi.nlm.nih.gov

A pilot test of Written Exposure Therapy for PTSD in residential substance use treatment. [2023]

10. England pubmed.ncbi.nlm.nih.gov

To reduce or abstain? Substance use goals in the treatment of veterans with substance use disorders and comorbid PTSD. [2020]