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| ID | Type | Description | Link |
|---|---|---|---|
| R01-13169-1 |
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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing |
|
| 2 | Active Comparator | Methadone plus behavioral counseling consisting of adherence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | dosed to effect, every six hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medication compliance and unauthorized drug use | 24 weeks | |
| Changes in pain severity and functioning | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with services | 12 weeks | |
| Therapeutic alliance | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Haller | St. Luke's Roosevelt Hosp Cntr (New York) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Science Research Unit | New York | New York | 10025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Haller, D.L., Heckman-Stone, C. Ingersoll, K.: Drug and Alcohol Dependence. 2002; 66, S73, #270 | ||
| Background | Wunsch, M.J., Cropsey, K.L., Haller, D.L.: Drug and Alcohol Dependence. 2002; 66, S198, #747 | ||
| Background | Fox, S.A., Haller, D.L., Weaver, M.F.: Proceedings from CPDD 2003 Annual Meeting, Bal Harbour, Florida. #197 | ||
| Background | Paper presented at the American Academy of Addiction Psychiatry, December, 2004 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D002908 | Chronic Disease |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| D010335 | Pathologic Processes |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |