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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

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

Study 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.

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

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,496 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment have an age limit of less than sixty years?

"This medical research is seeking participants who are of majority age and below the retirement threshold."

Answered by AI

Are there any vacancies left for participants in this research?

"A look at the clinicaltrials.gov database reveals that this trial, which was first posted on March 1st 2018 and last updated August 12th 2022, is no longer active in recruiting patients. However, there are 663 other medical studies currently searching for participants to join their research."

Answered by AI

Who is eligible for participation in this research experiment?

"Eligibility criteria for this medical study requires that patients have a diagnosis of chronic pain and are aged between 18-65 years. 52 people need to be recruited in total."

Answered by AI