PainNCT01940588
Neuropsychoanalytic Treatment of Failed Back Surgery Syndrome-Opioid Dependence
An observational study of Pain, run by State University of New York - Upstate Medical University.
Trial summary
Opioid Dependent Patients who have failed back surgery syndrome are detoxified and treated with a neuropsychoanalytic paradigm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Neuropsychoanalytic therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jun 2013
- Phase
- Observational
- 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
Study population: Adults with failed back surgery syndrome and opioid use disorder 18 years of age and older
Who may be able to join
- Have failed back surgery syndrome.
- Have evidence of Opioid Dependence by meeting DSM-IV criteria and by Drug Abuse Screening Test > 4. (In case of a difference in these two measures, clinical staff will talk with the patient to adjudicate the difference.)
- Over 18
- Be able to understand spoken and written English
- Reside within 30 miles of the site of treatment for ease of followup
- Have health insurance or other ability to pay for treatment
Who cannot join
- Homeless
- Unable to give consent (e.g. neurological disorders, dementia, psychosis)
- Co-occurring incapacitating psychiatric disorder such as schizophrenia
- Pregnant
- Financial incentive to stay ill, such as a pending disability claim
- Member of a vulnerable population, including prisoners
About this study
Opioid Dependent Patients who have failed back surgery syndrome are detoxified and treated with a neuropsychoanalytic paradigm.
Read the detailed description
Patients were detoxified from opioid analgesics and treated with NSAIDs and other non-opioid analgesics, received neuropsychoanalytic therapy and low dose naltrexone. Patients kept a daily diary of: 0 - 10 pain, 0 - 10 function, hours worked, amount of alcohol drunk, illicit and licit drug use, number of health care provider appointments attended, number of self-help groups meetings attended across each of the six months of study. Six month outcomes of this approach with primary outcomes being sobriety, pain scores and function scores.
- Conditions
- Pain
- Being tested
- Neuropsychoanalytic therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychoanalytic therapyBehavioural
Psychotherapy, medication management
| Study group | Role | What they receive |
|---|---|---|
| Neuropsychoanalytic treatment | Outpatient detoxification, intensive neuropsychoanalytic therapy, low dose naltrexone, monthly evaluations for six months - case series approach. Receives: Behavioral: Neuropsychoanalytic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of pain
Detoxified patients followed for whether their pain improved.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo
- Responsible party
- Sponsor
- Investigators
- Brian Johnson, M.D., Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940588
- Sponsor's protocol ID
- 1 - bjohnson
- Status last verified
- Jan 2015
- First submitted
- 9 Sep 2013
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychoanalytic Treatment of Failed Back Surgery Syndrome-Opioid Dependence
- ClinicalTrials.gov ID
- NCT01940588
- Acronym / sponsor ID
- 1 - bjohnson
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- University at Buffalo
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Sep 2013 (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.
Opioid Dependent Patients who have failed back surgery syndrome are detoxified and treated with a neuropsychoanalytic paradigm.
Detailed description
Patients were detoxified from opioid analgesics and treated with NSAIDs and other non-opioid analgesics, received neuropsychoanalytic therapy and low dose naltrexone. Patients kept a daily diary of: 0 - 10 pain, 0 - 10 function, hours worked, amount of alcohol drunk, illicit and licit drug use, number of health care provider appointments attended, number of self-help groups meetings attended across each of the six months of study. Six month outcomes of this approach with primary outcomes being sobriety, pain scores and function scores.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuropsychoanalytic treatment | – | Behavioral: Neuropsychoanalytic therapyOutpatient detoxification, intensive neuropsychoanalytic therapy, low dose naltrexone, monthly evaluations for six months - case series approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with failed back surgery syndrome and opioid use disorder 18 years of age and older
Key inclusion criteria (6 listed)
- Have failed back surgery syndrome.
- Have evidence of Opioid Dependence by meeting DSM-IV criteria and by Drug Abuse Screening Test > 4. (In case of a difference in these two measures, clinical staff will talk with the patient to adjudicate the difference.)
- Over 18
- Be able to understand spoken and written English
- Reside within 30 miles of the site of treatment for ease of followup
Key exclusion criteria (6 listed)
- Homeless
- Unable to give consent (e.g. neurological disorders, dementia, psychosis)
- Co-occurring incapacitating psychiatric disorder such as schizophrenia
- Pregnant
- Financial incentive to stay ill, such as a pending disability claim
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 |
|---|---|---|
| Neuropsychoanalytic therapyPsychotherapy, medication management | Behavioural | Neuropsychoanalytic treatment |
Primary outcome
Improvement of pain
Time frame: Six months
Detoxified patients followed for whether their pain improved.
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 6 Jan 2015.
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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.
Brian Johnson, M.D. principal investigator
State University of New York - Upstate Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by State University of New York - Upstate Medical University.
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 6 inclusion and 6 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 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Improvement of pain (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2015.