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Completed

NCT Number: NCT01940588

Neuropsychoanalytic Treatment of Failed Back Surgery Syndrome-Opioid Dependence

Opioid Dependent Patients who have failed back surgery syndrome are detoxified and treated with a neuropsychoanalytic paradigm.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Neuropsychoanalytic therapy

Behavioral

Psychotherapy, medication management

Primary outcomes

  1. Improvement of pain

    Time frame: Six months

    Detoxified patients followed for whether their pain improved.

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Collaborators

  • University at Buffalo

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 12, 2013
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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