New treatment option for Opioid Use Disorder
Official title Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery
ClinicalTrials.gov ID: NCT07115030
What this study is testing
- What it's testing
- Using a hybrid type 1 effectiveness-implementation approach, this study aims to evaluate the impact of a novel stepped care model ("PCT+2HOPE") versus treatment as usual (TAU) on increasing retention in community-based medication for opioid use disorder (MOUD) treatment among women who have experienced intimate partner violence (W-IPV). PCT+2HOPE includes Present-Centered Therapy (PCT+) with stepped care as indicated by moderate, severe, or extreme PTSD-related impairment in psychosocial functioning to Helping to Overcome PTSD through Empowerment (HOPE), two evidence-based behavioral interventions adapted for women with opioid use disorder (OUD).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Woman;
- Are ≥ 18 years old;
- Receive MOUD treatment at one of the participating sites;
- Have received MOUD for \>14 days to allow for initial stabilization;
- Have initiated the current treatment episode within the past 12 months;
You likely can't join if
- Fail a capacity-to-consent questionnaire;
- Have an unstable medical condition (e.g., hospitalization, planned surgery, newly starting chemotherapy, plans for palliative care) and/or unstable...
- Will be unavailable for \>4 consecutive weeks during the study period (e.g., anticipated move, planned surgery);
- Are unable to read/understand English;
- Inability to provide at least one form of contact
See the full eligibility criteria
- Woman;
- Are ≥ 18 years old;
- Receive MOUD treatment at one of the participating sites;
- Have received MOUD for \>14 days to allow for initial stabilization;
- Have initiated the current treatment episode within the past 12 months;
- Experienced physical or psychological IPV in their lifetime;
- Have at least moderate impairment in psychosocial functioning (on B-IPF) as a result of PTSD symptoms;
- Available during the date/time of the intervention group
- Able to read/understand English; and
- Provide written informed consent.
- Fail a capacity-to-consent questionnaire;
- Have an unstable medical condition (e.g., hospitalization, planned surgery, newly starting chemotherapy, plans for palliative care) and/or unstable psychiatric illness (e.g., untreated psychosis) that would interfere...
- Will be unavailable for \>4 consecutive weeks during the study period (e.g., anticipated move, planned surgery);
- Are unable to read/understand English;
- Inability to provide at least one form of contact
The study team makes the final eligibility decision.
Where it's taking place
- Bridgeport, Connecticut, United States
- Enfield, Connecticut, United States
- West Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bridgeport, Connecticut, United States; Enfield, Connecticut, United States; West Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.