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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Daily Functioning - Pain

Secondary study objectives

Changes in Substance Use

Other study objectives

Addiction Severity Index

Coping

Craving - Brief Substance Craving Inventory

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met