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Completed

NCT Number: NCT03363243

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Denver, Colorado, 80204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STOP Therapy Treatment group

Other

Testing of the STOP Therapy protocol

Treatment as usual (TAU) group

Other

Treatment as usual in the community through group therapy

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Dec 6, 2017
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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