Medication Adherence Therapy for Opioid Abusing Pain Patients

Phase 1

Completed

• Conditions: Prescription Opioid Abuse; Pain; Chronic Disease
• Interventions: Drug: Methadone

• Registration Number: NCT00249587
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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

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 Timeline

• Study Start: 2000-09
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-07
• Status Verified: 2008-09
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Methadone	Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing
2	Methadone	Methadone plus behavioral counseling consisting of adherence

Primary Outcome Measures

Name	Time	Method
Medication compliance and unauthorized drug use	24 weeks
Changes in pain severity and functioning	24 weeks

Secondary Outcome Measures

Name	Time	Method
Satisfaction with services	12 weeks
Therapeutic alliance	12 weeks

Trial Locations

Locations (1)

Behavioral Science Research Unit; 🇺🇸 New York, New York, United States