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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03363243
• Other study ID #: 17-1849
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: June 30, 2024
• Est. primary completion date: April 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Other:
• STOP Therapy Treatment group
Testing of the STOP Therapy protocol
• Treatment as usual (TAU) group
Treatment as usual in the community through group therapy

Locations

Country	Name	City	State
United States	University of Colorado Denver	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Substance Use, self-report	Timeline Follow back self report (Report alcohol/drug that you may have used in the past two weeks)	Weekly through study completion, approximately 4-5 months for each participant
Other	Pain assessment through Cold Pressor task	Cold pressor task assessment measures: 0-100 acute pain levels after task (0 being no pain, 100 being extreme pain), pain sensitivity (duration in water until reported feeling pain), pain tolerance (length of time hand is kept in cold water), physiological response to cold water	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
Other	Daily Functioning - Timed up and go	Timed up and go test - measure of function with correlates to balance and fall risk; participant is timed while getting up from a chair, walking, and returning to a seated position; scores of greater than or equal to 14 seconds indicate higher fall risk.	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
Other	Daily functioning - physical performance	Modified Physical performance test - 9 items in which participant performs basic physical activities: Standing Static Balance, Chair rise, Lift book, Put on jacket, Pick up penny, turn 360 degrees, 50 ft walk test, climb one flight of stairs, climb stairs (max. 4 flights); items are scored 0 to 4 based on time to complete task (with 0 being unable to complete task, 1 being longest timeframe to complete task and 4 being shortest 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
Other	Current pain levels	0-100 Current pain rating scale (with 0 being no pain, 100 being extreme pain)	Weekly through study completion, approximately 4-5 months for each participant
Other	Self-efficacy - Drug abstinence	Drug abstinence self-efficacy scale - 12 items, 1-5 scale (1 being not at all confident, 5 being extremely confident)	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
Other	Pain Catastrophizing	Pain Catastrophizing scale - assesses 13 items on a 0-4 scale (0-not at all, 1-to a slight degree, 2-to a moderate degree, 3-to a great degree, or 4-all the time)	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
Other	Self-efficacy - Pain	Pain self-efficacy questionnaire - 10 items, 0-6 scale (0 - not at all confident, 6 - extremely confident)	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
Other	Craving - Brief Substance Craving Inventory	Brief Substance Craving Inventory - self-report of drug cravings within the past 24 hours	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
Other	Craving - Current Craving levels	Desire for Drug and current craving levels questionnaire - 14 items, 1-7 scale (1-not at all, 7- very much)	assessed weekly from 2nd week through 13th week for each participant
Other	Distress Tolerance Scale	Distress tolerance scale - 15 items, rate from "strong agree" to "strong disagree"	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)
Other	Coping	Brief Cope Inventory - items rated from "never" to "always" on 28 items related to coping	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
Other	Positive and Negative Affect Scale	PANAS - ratings for how a participant has felt in the past two weeks, from 1 ("very slightly or not at all") to 5 ("extremely")	assessed weekly from 2nd week through 13th week for each participant
Other	Addiction Severity Index	ASI - survey on participant's baseline addiction severity; 5 parts (Background, Basic Health, Relationships, Alcohol and Drug Use, Legal situation)	assessed at initial session (week 1)
Other	Hospital Anxiety and Depression scale	HADS - asks participants to indicate how they generally feel on 14 items	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
Other	Session feedback	12 items, 1 for each weekly therapy topic, participants rate from 1 (very useful and will definitely use the strategies discussed) to 4 (not very useful and may not use the strategies discussed)	weekly through study completion, approximately 4-5 months for each participant
Other	Weekly attendance data sheet	table indicating which participants and the total number of participants that attend the therapy group each week	weekly through study completion, approximately 4-5 months for each participant
Other	Eligibility phone screening	6 yes or no items for inclusion/exclusion criteria, 1 open-ended item to provide medication and dosage frequency, 1 item to provide typical pain level on 0-10 scale	assessed at initial session (week 1) for each participant
Other	Demographics data sheet	demographics information	assessed at initial session (week 1) for each participant
Primary	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	Changes in Substance Use	urinalysis toxicity screening	Baseline (week 1), then assessed weekly over the course of the therapy treatment (approximately 4-5 months for each participant)