Medication Adherence Therapy for Opioid Abusing Pain Patients

National Institute on Drug Abuse (NIDA)36 enrolled

Overview

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.

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Chronic Disease Prescription Opioid Abuse

Interventions

MethadoneDRUG

dosed to effect, every six hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Behavioral Science Research Unit

New York, New York, United States

Outcomes

Primary Outcomes

Medication compliance and unauthorized drug use

Time frame: 24 weeks

Changes in pain severity and functioning

Time frame: 24 weeks

Secondary Outcomes

Satisfaction with services

Time frame: 12 weeks

Therapeutic alliance

Time frame: 12 weeks

Data from ClinicalTrials.gov

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