Medication Adherence Therapy for Opioid Abusing Pain Patients

Study Overview
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Brief Summary
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The purpose of this study is to develop and pilot test a combined behavioral and pharmacological intervention designed to decrease pain, functional interference, and drug abuse while increasing medication adherence.

Detailed Description
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Project Pain is a Stage I behavioral therapies development project aimed at developing and pilot testing a novel intervention for patients with chronic non-malignant pain who have experienced difficulty managing prescribed opioids. The goals of the study are to: (1) develop the intervention and training materials; (2) develop therapist adherence and competence scales; (3) train therapists to deliver the intervention per the treatment protocol; and (4) pilot the intervention to assess its feasibility, acceptability and promise. The goals of the intervention are to: (1) improve adherence to prescribed opioids; (2) decrease the severity of patients' pain; and (3) improve patients' functioning and quality of life .

Official Title
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Medication Adherence Therapy for Opioid Abusing Pain Patients

Conditions
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Pain, Chronic Disease, Prescription Opioid Abuse

Intervention / Treatment
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* Drug: Methadone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uninterrupted pain of at least 6 months duration Pain is continuous, rather than intermittent Pain in the severe range (VAS = 7-10) while medicated Poor response to non-pharmacological interventions for pain (if appropriate) One or more of the following pain diagnoses: (a) back/neck pain; (b) myofacial pain; (c) neuropathic pain (e.g., diabetic or AIDS neuropathy, Complex regional pain syndrome); (d) arthritic pain; (e) MS; or (f) sickle cell (must meet chronicity criteria) Evidence of tolerance/physiological dependence on opioid analgesics Current opioid use disorder (DSM-IV criteria) Continuous use of opioid analgesics for a minimum of 6 months prior to referral. [Note: This is consistent with minimum 6-month requirement for diagnosis of chronic pain]. Minimum of 2 signs/symptoms of medication mismanagement identified by the Referring MD (PROBLEMS WITH PAIN MEDS checklist) Exclusion Criteria: Please contact site regarding exclusion criteria for this study.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing | Drug: Methadone<br>* dosed to effect, every six hours<br>|
| Active Comparator: 2<br>Methadone plus behavioral counseling consisting of adherence | Drug: Methadone<br>* dosed to effect, every six hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication compliance and unauthorized drug use |  | 24 weeks | 
| Changes in pain severity and functioning |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with services |  | 12 weeks | 
| Therapeutic alliance |  | 12 weeks |