Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain

Study Overview
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Brief Summary
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The public health relevance of this proposed project is substantial given the current opioid abuse epidemic as identified by the Centers for Disease Control (CDC). This study finalizes and tests a new psychotherapy treatment that is designed to treat chronic pain and opioid addiction at the same time in a format that could be easily used in a community addiction treatment setting. Final products of the study will yield an integrated STOP (Self-regulation/Cognitive-behavioral therapy (CBT) Therapy for Opioid addiction and Pain) manual guided protocol, patient workbook, and therapist training protocol.

Official Title
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Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain

Conditions
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Opioid-use Disorder, Chronic Pain

Intervention / Treatment
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* Other: STOP Therapy Treatment group
* Other: Treatment as usual (TAU) group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old; Willing to adhere to study protocol including treatment sessions and assessments; Individuals have a history of co-morbid opioid use disorder and chronic pain; Cognitively able to participate and give informed consent. Exclusion Criteria: Acute or unstable psychotic disorder; Psychiatric hospitalization or suicide attempt in the past 3 months Patient has been diagnosed with an unstable cardiovascular condition including: myocardial infarction, arrhythmia, or poorly controlled hypertension in the past 3 months Lack of verbal and written English fluency Over the age of 65 since evidence suggests pain perception alters with age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1 Treatment group with STOP therapy; 1 Treatment as usual group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STOP Therapy Treatment group<br>Self-regulation Treatment for Opioid addiction and Pain (STOP) is a 12-week, rolling entry group therapy protocol that underwent initial development in a previous K23 study. Treatment consists of weekly 90-minute CBT+SR (Self Regulation) treatment with skill building exercises for co-morbid opioid addiction and pain. STOP will be provided in lieu of TAU (Treatment as Usual) group therapy. | Other: STOP Therapy Treatment group<br>* Testing of the STOP Therapy protocol<br>|
| Active Comparator: Treatment as usual (TAU) group<br>Psychotherapy for Addiction in conjunction with medication assisted treatment. Standard community treatment for opioid addiction consists of 90-minute weekly rolling entry addiction treatment for 12 weeks to allow for the learning and rehearsal of skills designed to reduce relapse. | Other: Treatment as usual (TAU) group<br>* Treatment as usual in the community through group therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Daily Functioning - Pain | Multi-dimensional pain inventory - 60 items (participant ratings 0 to 6 on various measures, from none to extreme or from never to very often, related to their pain and functioning); subscales (ratings in each subscale are averaged to form subscale scores): Interference, Support, Pain Severity, Life-Control, Affective Distress, Negative Responses, Solicitous Responses, Distracting Responses, Household Chores, Outdoor Work, Activities Away from Home, Social Activities, General Activity | Baseline (week 1) to post-treatment assessment time-point (week 14) and to a 1-month post-treatment follow-up assessment for each participant (approximately 4-5 month total time frame per participant) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Substance Use | urinalysis toxicity screening | Baseline (week 1), then assessed weekly over the course of the therapy treatment (approximately 4-5 months for each participant) |