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STOP Therapy for Opioid Addiction and Chronic Pain

N/A
Waitlist Available
Led By Amy B Wachholtz, PhD, MDiv, MS
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-65 years old
Cognitively able to participate and give informed consent
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Summary

This trial will test a new psychotherapy treatment that is designed to treat chronic pain and opioid addiction at the same time.

Who is the study for?
This trial is for adults aged 18-65 with both chronic pain and opioid addiction, who can understand the study and agree to its rules. It's not for those over 65, people with recent severe mental health issues or unstable heart conditions, or those who don't speak English well.Check my eligibility
What is being tested?
The trial tests a new therapy called STOP (Self-regulation/Cognitive-behavioral Therapy) designed to treat chronic pain and opioid addiction together. Participants will either receive this new treatment or continue with their usual care.See study design
What are the potential side effects?
Since STOP involves psychotherapy without medications, side effects may include emotional discomfort due to discussing personal issues but are generally considered low risk compared to medication treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I understand the information given to me and can make decisions about my health care.
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I have a history of opioid addiction and chronic pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a heart attack, irregular heartbeat, or uncontrolled high blood pressure in the last 3 months.
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I am not fluent in English, both in speaking and writing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Daily Functioning - Pain
Secondary outcome measures
Changes in Substance Use
Other outcome measures
Addiction Severity Index
Coping
Craving - Brief Substance Craving Inventory
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: STOP Therapy Treatment groupExperimental Treatment1 Intervention
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.
Group II: Treatment as usual (TAU) groupActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,758 Previous Clinical Trials
2,166,208 Total Patients Enrolled
Amy B Wachholtz, PhD, MDiv, MSPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

STOP Therapy Treatment group Clinical Trial Eligibility Overview. Trial Name: NCT03363243 — N/A
Opioid Use Disorder Research Study Groups: Treatment as usual (TAU) group, STOP Therapy Treatment group
Opioid Use Disorder Clinical Trial 2023: STOP Therapy Treatment group Highlights & Side Effects. Trial Name: NCT03363243 — N/A
STOP Therapy Treatment group 2023 Treatment Timeline for Medical Study. Trial Name: NCT03363243 — N/A
~7 spots leftby Jul 2025