Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363243
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Chronic Pain Other: STOP Therapy Treatment group Other: Treatment as usual (TAU) group Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1 Treatment group with STOP therapy; 1 Treatment as usual group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: STOP Therapy Treatment group
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.
Other: STOP Therapy Treatment group
Testing of the STOP Therapy protocol

Active Comparator: Treatment as usual (TAU) group
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.
Other: Treatment as usual (TAU) group
Treatment as usual in the community through group therapy




Primary Outcome Measures :
  1. Changes in Daily Functioning - Pain [ 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) ]
    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 :
  1. Changes in Substance Use [ Time Frame: Baseline (week 1), then assessed weekly over the course of the therapy treatment (approximately 4-5 months for each participant) ]
    urinalysis toxicity screening


Other Outcome Measures:
  1. Substance Use, self-report [ Time Frame: Weekly through study completion, approximately 4-5 months for each participant ]
    Timeline Follow back self report (Report alcohol/drug that you may have used in the past two weeks)

  2. Pain assessment through Cold Pressor task [ 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 ]
    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

  3. Daily Functioning - Timed up and go [ 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 ]
    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.

  4. Daily functioning - physical performance [ 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 ]
    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)

  5. Current pain levels [ Time Frame: Weekly through study completion, approximately 4-5 months for each participant ]
    0-100 Current pain rating scale (with 0 being no pain, 100 being extreme pain)

  6. Self-efficacy - Drug abstinence [ 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 ]
    Drug abstinence self-efficacy scale - 12 items, 1-5 scale (1 being not at all confident, 5 being extremely confident)

  7. Pain Catastrophizing [ 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 ]
    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)

  8. Self-efficacy - Pain [ 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 ]
    Pain self-efficacy questionnaire - 10 items, 0-6 scale (0 - not at all confident, 6 - extremely confident)

  9. Craving - Brief Substance Craving Inventory [ 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 ]
    Brief Substance Craving Inventory - self-report of drug cravings within the past 24 hours

  10. Craving - Current Craving levels [ Time Frame: assessed weekly from 2nd week through 13th week for each participant ]
    Desire for Drug and current craving levels questionnaire - 14 items, 1-7 scale (1-not at all, 7- very much)

  11. Distress Tolerance Scale [ 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) ]
    Distress tolerance scale - 15 items, rate from "strong agree" to "strong disagree"

  12. 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 ]
    Brief Cope Inventory - items rated from "never" to "always" on 28 items related to coping

  13. Positive and Negative Affect Scale [ Time Frame: assessed weekly from 2nd week through 13th week for each participant ]
    PANAS - ratings for how a participant has felt in the past two weeks, from 1 ("very slightly or not at all") to 5 ("extremely")

  14. Addiction Severity Index [ Time Frame: assessed at initial session (week 1) ]
    ASI - survey on participant's baseline addiction severity; 5 parts (Background, Basic Health, Relationships, Alcohol and Drug Use, Legal situation)

  15. Hospital Anxiety and Depression scale [ 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 ]
    HADS - asks participants to indicate how they generally feel on 14 items

  16. Session feedback [ Time Frame: weekly through study completion, approximately 4-5 months for each participant ]
    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)

  17. Weekly attendance data sheet [ Time Frame: weekly through study completion, approximately 4-5 months for each participant ]
    table indicating which participants and the total number of participants that attend the therapy group each week

  18. Eligibility phone screening [ Time Frame: assessed at initial session (week 1) for each participant ]
    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

  19. Demographics data sheet [ Time Frame: assessed at initial session (week 1) for each participant ]
    demographics information



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363243


Contacts
Layout table for location contacts
Contact: Sarah Martin, MS 303-315-7036 sarah.c.martin@ucdenver.edu

Locations
Layout table for location information
United States, Colorado
UC Denver Recruiting
Denver, Colorado, United States, 80204
Contact: Caitlin A Kienzler         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Amy B Wachholtz, PhD, MDiv, MS University of Colorado, Denver
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03363243    
Other Study ID Numbers: 17-1849
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders