Medication Adherence Therapy for Opioid Abusing Pain Patients

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Chronic Disease

Prescription Opioid Abuse

Pain

Treatments

Drug: Methadone

Study type

Interventional

Funder types

NIH

Identifiers

NCT00249587

NIDA-13169-1

R01-13169-1

Details and patient eligibility

About

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.

Full description

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 .

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)