Neuropsychoanalytic Treatment of Failed Back Surgery Synd... | NCT01940588

Studies
Neuropsychoanalytic Treatment of Failed Back Surgery Syndrome-Opioid Dependence

NCT01940588

Sponsor

State University of New York - Upstate Medical University

Status

Completed

Last Update Posted

Jan 6, 2015Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Pain

Interventions

Neuropsychoanalytic therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Sep 9, 2013

First Submission Date that Met QC Criteria

Sep 11, 2013

First Posted Date

Sep 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2015

Last Update Posted Date

Jan 6, 2015Estimated

Name	Class
University at Buffalo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neuropsychoanalytic treatment		Outpatient detoxification, intensive neuropsychoanalytic therapy, low dose naltrexone, monthly evaluations for six months - case series approach.	Behavioral: Neuropsychoanalytic therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuropsychoanalytic therapy	Behavioral	Psychotherapy, medication management	Neuropsychoanalytic treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian Johnson, M.D.	State University of New York - Upstate Medical University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided