Pilot Study of Combined Treatment for Veterans With Chronic Pain & Opiate Misuse

Study Overview
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Brief Summary
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Chronic pain and misuse of opioids is a major public health problem, particularly in military veterans. The major goal of this project is to test the efficacy of an innovative behavioral treatment for chronic pain patients who are misusing prescription opiates. This project supports the strategic goals of National Center for Complementary and Integrative Health (NCCIH) and National Institute on Drug Abuse by examining a difficult and understudied problem with the ultimate goal of impacting scientific knowledge and human health.

Detailed Description
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Opioid prescription in the treatment of chronic pain is frequent and carries a consequent risk of poor treatment outcome, as well as higher morbidity and mortality in a clinically significant number of patients, particularly those who meet criteria for opioid dependence. Despite the alarming increases (140% increase from 1992 to 2003) in prescription opiate misuse, abuse, and dependence nationally in the United States, there are few treatment options available that target both pain-related interference and opioid dependence among patients with chronic pain. In military veterans, this issue is of particular importance as numerous reports indicate increasing use of opioids in the treatment of chronic pain, as well as increasing opioid-related problems, specifically in those who served in the Iraq and Afghanistan theatres [Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND)]. To date, there are no evidenced-based treatment options which aim to both maximize effective functioning in Veterans with chronic pain while simultaneously addressing problematic opioid use. The overall aim of the present study will be to determine the feasibility of an integrated psychosocial treatment in veterans with chronic pain, who also have evidence of opioid-related misuse. To examine this aim, the investigators will utilize a randomized design to assess the feasibility of integrating two empirically supported interventions: Acceptance and Commitment Therapy for chronic pain and Mindfulness Based Relapse Prevention for substance use and misuse. Feasibility will be assessed by examining rates of recruitment and retention of participants through a six month follow-up. In addition, the investigators will evaluate progress within-treatment on specific therapy targets to aid in the identification of potential treatment mechanisms. The results of this study will directly inform treatment of chronic pain patients and represents a significant advance in the growing and understudied problem of opiate misuse among chronic pain patients. In addition to addressing the question of whether the treatment is feasible, it will further examine issues of treatment mechanisms to better inform the design of a randomized and controlled trial assessing treatment efficacy.

Official Title
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Pilot Study of Combined Treatment for Veterans With Chronic Pain & Opiate Misuse

Conditions
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Chronic Pain, Problematic Opioid Use

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 21-65 years old Diagnosis of chronic pain condition Pain severity over the past seven days of four or greater on a 0-10 scale Prescribed opioids for the treatment of chronic pain for the past 90 days or longer Ability to read written English Exclusion Criteria: Meet diagnostic criteria for current substance abuse/dependence on a drug other than opioids Meet diagnostic criteria for a current or past DSM diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders, Currently prescribed medications for opioid addiction (e.g., Buprenorphine/Naloxone/Suboxone). History of suicide attempts or inpatient hospitalization for risk of suicide in the past six month. In addition, we will screen for significant suicidal

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Treatment as usual, plus 12 weeks of group based intervention to improve functioning and decrease problematic effects of opioid use. | Behavioral: Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)<br> <br> |
| No Intervention: Treatment as Usual<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Behavior |  | Change from baseline (i.e., the beginning of the intervention) in Pain behavior, as measured by PROMIS at 9 months | 
| Patient Reported Outcomes Measurement Information System (PROMIS) - Pain Interference |  | Change from baseline (i.e., the beginning of the intervention) in Pain Interference as measured by PROMIS at 9 months | 
| Current Opioid Misuse Measure (COMM) |  | Change from baseline (i.e., the beginning of the intervention) in Current Opioid Misuse, as measured by COMM at 9 months |