Back to resultsMedication Adherence Therapy for Opioid Abusing Pain Patients
Primary Purpose
Pain, Chronic Disease, Prescription Opioid Abuse
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methadone
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility 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.
Sites / Locations
- Behavioral Science Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing
Methadone plus behavioral counseling consisting of adherence
Outcomes
Primary Outcome Measures
Medication compliance and unauthorized drug use
Changes in pain severity and functioning
Secondary Outcome Measures
Satisfaction with services
Therapeutic alliance
Full Information
NCT ID
NCT00249587
First Posted
November 3, 2005
Last Updated
January 9, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00249587
Brief Title
Medication Adherence Therapy for Opioid Abusing Pain Patients
Official Title
Medication Adherence Therapy for Opioid Abusing Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Disease, Prescription Opioid Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing
Arm Title
2
Arm Type
Active Comparator
Arm Description
Methadone plus behavioral counseling consisting of adherence
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
dosed to effect, every six hours
Primary Outcome Measure Information:
Title
Medication compliance and unauthorized drug use
Time Frame
24 weeks
Title
Changes in pain severity and functioning
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Satisfaction with services
Time Frame
12 weeks
Title
Therapeutic alliance
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Haller
Organizational Affiliation
St. Luke's Roosevelt Hosp Cntr (New York)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Science Research Unit
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Haller, D.L., Heckman-Stone, C. Ingersoll, K.: Drug and Alcohol Dependence. 2002; 66, S73, #270
Results Reference
background
Citation
Wunsch, M.J., Cropsey, K.L., Haller, D.L.: Drug and Alcohol Dependence. 2002; 66, S198, #747
Results Reference
background
Citation
Fox, S.A., Haller, D.L., Weaver, M.F.: Proceedings from CPDD 2003 Annual Meeting, Bal Harbour, Florida. #197
Results Reference
background
Citation
Paper presented at the American Academy of Addiction Psychiatry, December, 2004
Results Reference
background
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Medication Adherence Therapy for Opioid Abusing Pain Patients
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