Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy

Study Overview
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Brief Summary
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Chronic back pain patients are often dismissed from a pain center or a primary care practice when they are noncompliant with opioid therapy, instead of being offered treatments to reduce misuse and to improve compliance. Unfortunately, there are few treatment resources for such patients. This study seeks to remedy that problem, with the goal of reducing the rate of prescription opioid misuse among noncompliant patients through the use of novel tracking, education, and counseling interventions.

Detailed Description
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This study will evaluate drug misuse behavior over 6 months with the use of self-report questionnaires, physician ratings, urine toxicology screens, and electronic diary data.

Official Title
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Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy

Conditions
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Substance Abuse

Intervention / Treatment
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* Behavioral: cognitive behavioral training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic pain for >6 months history of taking daily opioids for pain for >6 months average >3 on a pain intensity scale of 0 to 10 over past week able to speak and understand English chronic neck or back pain as primary pain complaint willingness to participate Exclusion Criteria: current opioid addiction (M.I.N.I. Section K) current diagnosis of cancer or any other malignant disease acute osteomyelitis or acute bone disease nonambulatory present or past DSM-IV diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder pregnancy any clinically unstable systemic illness judged to interfere with treatment an acute condition requiring surgery taking opioids intermittently

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: High-Risk No Treatment<br> | |
| Experimental: High-Risk Treatment<br> | Behavioral: cognitive behavioral training<br>* electronic diaries, compliance checklists, urine screens, individual and group motivational counseling<br>* Other names: therapy;|
| No Intervention: Low-Risk<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Misuse Index: 1) physician ratings of misuse (ABC), 2) structured self-report interview (PDUQ), and 3) urine tox screens |  | All subjects will be followed for 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings |  | Subjects will be followed for 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, opioids