NCT01940588

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

September 9, 2013

Last Update Submit

January 5, 2015

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Improvement of pain

    Detoxified patients followed for whether their pain improved.

    Six months

Study Arms (1)

Neuropsychoanalytic treatment

Outpatient detoxification, intensive neuropsychoanalytic therapy, low dose naltrexone, monthly evaluations for six months - case series approach.

Behavioral: Neuropsychoanalytic therapy

Interventions

Neuropsychoanalytic therapyBEHAVIORAL

Psychotherapy, medication management

Neuropsychoanalytic treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian Johnson, M.D.

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 12, 2013

Study Start

March 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 6, 2015

Record last verified: 2015-01