Medication Adherence Therapy for Opioid Abusing Pain Patients
Overview
- Phase
- Phase 1
- Intervention
- Methadone
- Conditions
- Pain
- Sponsor
- National Institute on Drug Abuse (NIDA)
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Medication compliance and unauthorized drug use
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 .
Investigators
Eligibility Criteria
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.
Arms & Interventions
1
Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing
Intervention: Methadone
2
Methadone plus behavioral counseling consisting of adherence
Intervention: Methadone
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(12 weeks)
- Therapeutic alliance(12 weeks)