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

NCT ID: NCT03363243

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2024-06-30

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.

Conditions

Opioid-use Disorder; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

STOP Therapy Treatment group

Intervention Type: OTHER

Testing of the STOP Therapy protocol

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.

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU) group

Intervention Type: OTHER

Treatment as usual in the community through group therapy

Interventions

STOP Therapy Treatment group

Testing of the STOP Therapy protocol

Intervention Type: OTHER

Treatment as usual (TAU) group

Treatment as usual in the community through group therapy

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy B Wachholtz, PhD, MDiv, MS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Denver, Colorado, United States

Countries

United States

References

Wachholtz A, Robinson D, Epstein E. Developing a novel treatment for patients with chronic pain and Opioid User Disorder. Subst Abuse Treat Prev Policy. 2022 May 7;17(1):35. doi: 10.1186/s13011-022-00464-4.

Reference Type: DERIVED

PMID: 35525964 (View on PubMed)

Other Identifiers

17-1849

Identifier Type: -

Identifier Source: org_study_id