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

Not Applicable

Completed

• Conditions: Chronic Pain; Opioid-use Disorder
• Interventions: Other: Treatment as usual (TAU) group; Other: STOP Therapy Treatment group

• Registration Number: NCT03363243
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-06
• Study Start: 2018-03-01
• Primary Completion: 2022-04-21
• Study Completion: 2024-06-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. 18-65 years old;
2. Willing to adhere to study protocol including treatment sessions and assessments;
3. Individuals have a history of co-morbid opioid use disorder and chronic pain;
4. Cognitively able to participate and give informed consent.

Exclusion Criteria

1. Acute or unstable psychotic disorder;
2. Psychiatric hospitalization or suicide attempt in the past 3 months
3. Patient has been diagnosed with an unstable cardiovascular condition including: myocardial infarction, arrhythmia, or poorly controlled hypertension in the past 3 months
4. Lack of verbal and written English fluency
5. Over the age of 65 since evidence suggests pain perception alters with age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual (TAU) group	Treatment as usual (TAU) group	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.
STOP Therapy Treatment group	STOP Therapy Treatment group	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.

Primary Outcome Measures

Name	Time	Method
Changes in Daily Functioning - Pain	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)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Denver, Colorado, United States