Neuropsychoanalytic Treatment of Failed Back Surgery Syndrome-Opioid Dependence

January 5, 2015 updated by: State University of New York - Upstate Medical University
Opioid Dependent Patients who have failed back surgery syndrome are detoxified and treated with a neuropsychoanalytic paradigm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with failed back surgery syndrome and opioid use disorder 18 years of age and older

Description

Inclusion Criteria:

  1. Have failed back surgery syndrome.
  2. 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.)
  3. Over 18
  4. Be able to understand spoken and written English
  5. Reside within 30 miles of the site of treatment for ease of followup
  6. Have health insurance or other ability to pay for treatment

Exclusion Criteria:

  1. Homeless
  2. Unable to give consent (e.g. neurological disorders, dementia, psychosis)
  3. Co-occurring incapacitating psychiatric disorder such as schizophrenia
  4. Pregnant
  5. Financial incentive to stay ill, such as a pending disability claim
  6. Member of a vulnerable population, including prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neuropsychoanalytic treatment
Outpatient detoxification, intensive neuropsychoanalytic therapy, low dose naltrexone, monthly evaluations for six months - case series approach.
Behavioral: Neuropsychoanalytic therapy
Psychotherapy, medication management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of pain
Time Frame: Six months
Detoxified patients followed for whether their pain improved.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Collaborators

University at Buffalo

Investigators

  • Principal Investigator: Brian Johnson, M.D., State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 11, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 5, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 - bjohnson

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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