Clinical trial NCT03363243: Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain
Official title: Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Chronic Pain
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 Treatment group with STOP therapy; 1 Treatment as usual group
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in Daily Functioning - Pain
timeFrame: 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:
measure: Changes in Substance Use
timeFrame: Baseline (week 1), then assessed weekly over the course of the therapy treatment (approximately 4-5 months for each participant)
Other outcomes:
measure: Substance Use, self-report
timeFrame: Weekly through study completion, approximately 4-5 months for each participant
measure: Pain assessment through Cold Pressor task
timeFrame: 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
measure: Daily Functioning - Timed up and go
timeFrame: 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
measure: Daily functioning - physical performance
timeFrame: 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
measure: Current pain levels
timeFrame: Weekly through study completion, approximately 4-5 months for each participant
measure: Self-efficacy - Drug abstinence
timeFrame: 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
measure: Pain Catastrophizing
timeFrame: 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
measure: Self-efficacy - Pain
timeFrame: 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
measure: Craving - Brief Substance Craving Inventory
timeFrame: 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
measure: Craving - Current Craving levels
timeFrame: assessed weekly from 2nd week through 13th week for each participant
measure: Distress Tolerance Scale
timeFrame: 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)
measure: Coping
timeFrame: 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
measure: Positive and Negative Affect Scale
timeFrame: assessed weekly from 2nd week through 13th week for each participant
measure: Addiction Severity Index
timeFrame: assessed at initial session (week 1)
measure: Hospital Anxiety and Depression scale
timeFrame: 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
measure: Session feedback
timeFrame: weekly through study completion, approximately 4-5 months for each participant
measure: Weekly attendance data sheet
timeFrame: weekly through study completion, approximately 4-5 months for each participant
measure: Eligibility phone screening
timeFrame: assessed at initial session (week 1) for each participant
measure: Demographics data sheet
timeFrame: assessed at initial session (week 1) for each participant
Locations:
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Amy B Wachholtz, PhD, MDiv, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.