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.
Primary Outcome Measures:
- Medication compliance and unauthorized drug use [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Changes in pain severity and functioning [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Satisfaction with services [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Therapeutic alliance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: |
36 |
| Study Start Date: |
September 2000 |
| Study Completion Date: |
September 2005 |
| Primary Completion Date: |
September 2005 (Final data collection date for primary outcome measure) |
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1: Experimental
Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing
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Drug: Methadone
dosed to effect, every six hours
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2: Active Comparator
Methadone plus behavioral counseling consisting of adherence
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Drug: Methadone
dosed to effect, every six hours
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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 .
Purpose
