Back to resultsAdvancing STOP: Self-regulation Therapy for Opioid Addiction and Pain
Primary Purpose
Opioid-use Disorder, Chronic Pain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STOP Therapy Treatment group
Treatment as usual (TAU) group
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
Eligibility Criteria
Inclusion Criteria:
- 18-65 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.
Exclusion Criteria:
- 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
Sites / Locations
- University of Colorado Denver
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
STOP Therapy Treatment group
Treatment as usual (TAU) group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in Substance Use
urinalysis toxicity screening
Full Information
NCT ID
NCT03363243
First Posted
October 16, 2017
Last Updated
June 13, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03363243
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
April 21, 2022 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1 Treatment group with STOP therapy; 1 Treatment as usual group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STOP Therapy Treatment group
Arm Type
Experimental
Arm 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.
Arm Title
Treatment as usual (TAU) group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
STOP Therapy Treatment group
Intervention Description
Testing of the STOP Therapy protocol
Intervention Type
Other
Intervention Name(s)
Treatment as usual (TAU) group
Intervention Description
Treatment as usual in the community through group therapy
Primary Outcome Measure Information:
Title
Changes in Daily Functioning - Pain
Description
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 Outcome Measure Information:
Title
Changes in Substance Use
Description
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)
Other Pre-specified Outcome Measures:
Title
Substance Use, self-report
Description
Timeline Follow back self report (Report alcohol/drug that you may have used in the past two weeks)
Time Frame
Weekly through study completion, approximately 4-5 months for each participant
Title
Pain assessment through Cold Pressor task
Description
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
Time Frame
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
Title
Daily Functioning - Timed up and go
Description
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.
Time Frame
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
Title
Daily functioning - physical performance
Description
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)
Time Frame
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
Title
Current pain levels
Description
0-100 Current pain rating scale (with 0 being no pain, 100 being extreme pain)
Time Frame
Weekly through study completion, approximately 4-5 months for each participant
Title
Self-efficacy - Drug abstinence
Description
Drug abstinence self-efficacy scale - 12 items, 1-5 scale (1 being not at all confident, 5 being extremely confident)
Time Frame
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
Title
Pain Catastrophizing
Description
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)
Time Frame
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
Title
Self-efficacy - Pain
Description
Pain self-efficacy questionnaire - 10 items, 0-6 scale (0 - not at all confident, 6 - extremely confident)
Time Frame
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
Title
Craving - Brief Substance Craving Inventory
Description
Brief Substance Craving Inventory - self-report of drug cravings within the past 24 hours
Time Frame
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
Title
Craving - Current Craving levels
Description
Desire for Drug and current craving levels questionnaire - 14 items, 1-7 scale (1-not at all, 7- very much)
Time Frame
assessed weekly from 2nd week through 13th week for each participant
Title
Distress Tolerance Scale
Description
Distress tolerance scale - 15 items, rate from "strong agree" to "strong disagree"
Time Frame
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)
Title
Coping
Description
Brief Cope Inventory - items rated from "never" to "always" on 28 items related to coping
Time Frame
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
Title
Positive and Negative Affect Scale
Description
PANAS - ratings for how a participant has felt in the past two weeks, from 1 ("very slightly or not at all") to 5 ("extremely")
Time Frame
assessed weekly from 2nd week through 13th week for each participant
Title
Addiction Severity Index
Description
ASI - survey on participant's baseline addiction severity; 5 parts (Background, Basic Health, Relationships, Alcohol and Drug Use, Legal situation)
Time Frame
assessed at initial session (week 1)
Title
Hospital Anxiety and Depression scale
Description
HADS - asks participants to indicate how they generally feel on 14 items
Time Frame
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
Title
Session feedback
Description
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)
Time Frame
weekly through study completion, approximately 4-5 months for each participant
Title
Weekly attendance data sheet
Description
table indicating which participants and the total number of participants that attend the therapy group each week
Time Frame
weekly through study completion, approximately 4-5 months for each participant
Title
Eligibility phone screening
Description
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
Time Frame
assessed at initial session (week 1) for each participant
Title
Demographics data sheet
Description
demographics information
Time Frame
assessed at initial session (week 1) for each participant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy B Wachholtz, PhD, MDiv, MS
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35525964
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.
Results Reference
derived
Learn more about this trial
Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain
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