Medication Adherence Therapy for Opioid Abusing Pain Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2005-09-30

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.

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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 .

Conditions

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Pain Chronic Disease Prescription Opioid Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing

Group Type EXPERIMENTAL

Methadone

Intervention Type DRUG

dosed to effect, every six hours

2

Methadone plus behavioral counseling consisting of adherence

Group Type ACTIVE_COMPARATOR

Methadone

Intervention Type DRUG

dosed to effect, every six hours

Interventions

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Methadone

dosed to effect, every six hours

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No