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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Opioid-use Disorder; Chronic Pain

Treatments: Other: STOP Therapy Treatment group; Other: Treatment as usual (TAU) group

Study type: Interventional

Funder types: Other

Identifiers

NCT03363243

17-1849

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

52 participants in 2 patient groups

STOP Therapy Treatment group

Experimental group

Description:

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.

Treatment:

Other: STOP Therapy Treatment group

Treatment as usual (TAU) group

Active Comparator group

Description:

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.

Treatment:

Other: Treatment as usual (TAU) group