Chronic Disease, Pain, Prescription Opioid Abuse
Conditions
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 .
Interventions
DRUGMethadone
dosed to effect, every six hours
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medication compliance and unauthorized drug use | 24 weeks |
| Changes in pain severity and functioning | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction with services | 12 weeks |
| Therapeutic alliance | 12 weeks |
Countries
United States
Outcome results
None listed