PainPhase 1/2NCT00249587
Medication Adherence Therapy for Opioid Abusing Pain Patients
A Phase 1/2 study testing Methadone in people with Pain and Chronic Disease, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Disease, Prescription Opioid Abuse
- What is being tested?
- Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Sep 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- Please contact site regarding exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Science Research Unit
New York, New York, 10025
About this study
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.
Read the 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 .
- Conditions
- Pain, Chronic Disease, Prescription Opioid Abuse
- Being tested
- Methadone
- Medical subject headings
- Pain, Chronic Disease, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
dosed to effect, every six hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Methadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing Receives: Drug: Methadone |
| 2 | Active comparator | Methadone plus behavioral counseling consisting of adherence Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication compliance and unauthorized drug use
Measured: 24 weeks
Changes in pain severity and functioning
Measured: 24 weeks
Secondary outcomes (2)
Satisfaction with services
Measured: 12 weeks
Therapeutic alliance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startSep 2000
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Deborah Haller, Principal investigator, St. Luke's Roosevelt Hosp Cntr (New York)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249587
- Sponsor's protocol ID
- NIDA-13169-1
- Other IDs
- R01-13169-1
- Status last verified
- Sep 2008
- First submitted
- 3 Nov 2005
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Haller, D.L., Heckman-Stone, C. Ingersoll, K.: Drug and Alcohol Dependence. 2002; 66, S73, #270
Wunsch, M.J., Cropsey, K.L., Haller, D.L.: Drug and Alcohol Dependence. 2002; 66, S198, #747
Fox, S.A., Haller, D.L., Weaver, M.F.: Proceedings from CPDD 2003 Annual Meeting, Bal Harbour, Florida. #197
Paper presented at the American Academy of Addiction Psychiatry, December, 2004
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Adherence Therapy for Opioid Abusing Pain Patients
- ClinicalTrials.gov ID
- NCT00249587
- Acronym / sponsor ID
- NIDA-13169-1
- Conditions
- Pain, Chronic Disease, Prescription Opioid Abuse
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Sep 2000
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MethadoneMethadone plus behavioral counseling consisting of adherence, self-monitoring, and motivational interviewing |
| 2 | Active comparator | Drug: MethadoneMethadone plus behavioral counseling consisting of adherence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (1 listed)
- Please contact site regarding exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadonedosed to effect, every six hours | Drug | 1, 2 |
Primary outcome
Medication compliance and unauthorized drug use
Time frame: 24 weeks
Changes in pain severity and functioning
Time frame: 24 weeks
2 secondary outcomes
Satisfaction with services
Time frame: 12 weeks
Therapeutic alliance
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- BackgroundHaller, D.L., Heckman-Stone, C. Ingersoll, K.: Drug and Alcohol Dependence. 2002; 66, S73, #270
- BackgroundWunsch, M.J., Cropsey, K.L., Haller, D.L.: Drug and Alcohol Dependence. 2002; 66, S198, #747
- BackgroundFox, S.A., Haller, D.L., Weaver, M.F.: Proceedings from CPDD 2003 Annual Meeting, Bal Harbour, Florida. #197
- BackgroundPaper presented at the American Academy of Addiction Psychiatry, December, 2004
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Haller principal investigator
St. Luke's Roosevelt Hosp Cntr (New York)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Methadone in people with Pain and Chronic Disease, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication compliance and unauthorized drug use (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249587, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.