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

NCT03363243 | Completed

• 1 other identifier: 17-1849
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in Substance Use

  Baseline (week 1), then assessed weekly over the course of the therapy treatment (approximately 4-5 months for each participant)

Other Outcomes (19)

• Substance Use, self-report

  Weekly through study completion, approximately 4-5 months for each participant

• Pain assessment through Cold Pressor task

  Assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) for each participant

• Daily Functioning - Timed up and go

  Assessed at initial session (week 1), follow up (~12-13 weeks after initial session) and 1 month follow up (~4-5 months after initial session) for each participant

Study Arms (2)

STOP Therapy Treatment group

EXPERIMENTAL

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

Treatment as usual (TAU) group

ACTIVE COMPARATOR

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

Interventions

STOP Therapy Treatment group OTHER

Testing of the STOP Therapy protocol

STOP Therapy Treatment group

Treatment as usual (TAU) group OTHER

Treatment as usual in the community through group therapy

Treatment as usual (TAU) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• 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.

  PMID: 35525964 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Interventions

Therapeutics; Population Groups

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Amy B Wachholtz, PhD, MDiv, MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1 Treatment group with STOP therapy; 1 Treatment as usual group

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: December 6, 2017
• Study Start: March 1, 2018
• Primary Completion: April 21, 2022
• Study Completion: June 30, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

US (1)