Opioid-use DisorderNCT03363243
Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain
A study testing STOP Therapy Treatment group and Treatment as usual (TAU) group in people with Opioid-use Disorder and Chronic Pain, run by University of Colorado, Denver at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder, Chronic Pain
- What is being tested?
- STOP Therapy Treatment group and Treatment as usual (TAU) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Denver, Colorado, 80204
About this study
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.
- Conditions
- Opioid-use Disorder, Chronic Pain
- Being tested
- STOP Therapy Treatment group, Treatment as usual (TAU) group
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOP Therapy Treatment groupOther
Testing of the STOP Therapy protocol
Treatment as usual (TAU) groupOther
Treatment as usual in the community through group therapy
| Study group | Role | What they receive |
|---|---|---|
| STOP Therapy Treatment group | Experimental | 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. Receives: Other: STOP Therapy Treatment group |
| Treatment as usual (TAU) group | Active comparator | 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. Receives: Other: Treatment as usual (TAU) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (1)
Changes in Substance Use
urinalysis toxicity screening
Measured: Baseline (week 1), then assessed weekly over the course of the therapy treatment (approximately 4-5 months for each participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Mar 2018
- Primary completion21 Apr 2022
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1 Treatment group with STOP therapy; 1 Treatment as usual group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy B Wachholtz, PhD, MDiv, MS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363243
- Sponsor's protocol ID
- 17-1849
- Status last verified
- Mar 2025
- First submitted
- 16 Oct 2017
- Last updated
- 27 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35525964
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing STOP: Self-regulation Therapy for Opioid Addiction and Pain
- ClinicalTrials.gov ID
- NCT03363243
- Acronym / sponsor ID
- 17-1849
- Conditions
- Opioid-use Disorder, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 Treatment group with STOP therapy; 1 Treatment as usual group
| Arm | Type | Receives |
|---|---|---|
| STOP Therapy Treatment group | Experimental | Other: STOP Therapy Treatment groupSelf-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. |
| Treatment as usual (TAU) group | Active comparator | Other: Treatment as usual (TAU) groupPsychotherapy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STOP Therapy Treatment groupTesting of the STOP Therapy protocol | Other | STOP Therapy Treatment group |
| Treatment as usual (TAU) groupTreatment as usual in the community through group therapy | Other | Treatment as usual (TAU) group |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Derived from this study: PubMed 35525964Wachholtz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy B Wachholtz, PhD, MDiv, MS principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STOP Therapy Treatment group and Treatment as usual (TAU) group in people with Opioid-use Disorder and Chronic Pain, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03363243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.