Medication Adherence Therapy for Opioid Abusing Pain Patients
This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00249587
First received: November 3, 2005
Last updated: September 19, 2008
Last verified: September 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Chronic Disease Prescription Opioid Abuse |
Drug: Methadone |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Medication Adherence Therapy for Opioid Abusing Pain Patients |
Resource links provided by NLM:
Further study details as provided by National Institute on Drug Abuse (NIDA):
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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing
|
Drug: Methadone
dosed to effect, every six hours
|
|
Active Comparator: 2
Methadone plus behavioral counseling consisting of adherence
|
Drug: Methadone
dosed to effect, every six hours
|
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 .
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249587
Locations
| United States, New York | |
| Behavioral Science Research Unit | |
| New York, New York, United States, 10025 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Deborah Haller | St. Luke's Roosevelt Hosp Cntr (New York) |
More Information
Additional Information:
Publications:
Fox, S.A., Haller, D.L., Weaver, M.F.: Proceedings from CPDD 2003 Annual Meeting, Bal Harbour, Florida. #197
| Responsible Party: | Deborah Haller, Ph.D., St. Luke's-Roosevelt Hospital Center |
| ClinicalTrials.gov Identifier: | NCT00249587 History of Changes |
| Other Study ID Numbers: | NIDA-13169-1, R01-13169-1 |
| Study First Received: | November 3, 2005 |
| Last Updated: | September 19, 2008 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Chronic Disease Disease Attributes Pathologic Processes Methadone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013