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

March 24, 2025 updated by: University of Colorado, Denver
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline (week 1), then assessed weekly over the course of the therapy treatment (approximately 4-5 months for each participant)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Weekly through study completion, approximately 4-5 months for each participant
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
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
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.
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
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)
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
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)
Weekly through study completion, approximately 4-5 months for each participant
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)
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
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)
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
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)
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
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
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
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)
assessed weekly from 2nd week through 13th week for each participant
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"
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)
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
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
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")
assessed weekly from 2nd week through 13th week for each participant
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)
assessed at initial session (week 1)
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
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
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)
weekly through study completion, approximately 4-5 months for each participant
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
weekly through study completion, approximately 4-5 months for each participant
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
assessed at initial session (week 1) for each participant
Demographics data sheet
Time Frame: assessed at initial session (week 1) for each participant
demographics information
assessed at initial session (week 1) for each participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amy B Wachholtz, PhD, MDiv, MS, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-1849

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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