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

University of Colorado, Denver52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opioid-use Disorder Chronic Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Changes in Substance Use

urinalysis toxicity screening

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