The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain

NCT ID: NCT01840345

Last Updated: 2018-05-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-04-01

Brief Summary

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This study will test whether treatment with N-acetyl-L-cysteine (NAC) is safe and decreases pain in patients with chronic neuropathic pain. The investigators hypothesize that NAC will be a useful adjunct to opioid treatment in chronic neuropathic pain.

Detailed Description

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This is an open-label study to evaluate the safety and efficacy of N-acetyl-L-cysteine in patients with Chronic neuropathic pain.

Conditions

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Neuropathic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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N-acetyl-L-cysteine

n-acetyl-l-cysteine 1200 mg BID x 4 weeks

Group Type EXPERIMENTAL

N-acetyl-l-cysteine

Intervention Type DRUG

1200 mg BID x 4 weeks

Interventions

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N-acetyl-l-cysteine

1200 mg BID x 4 weeks

Intervention Type DRUG

Other Intervention Names

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NAC

Eligibility Criteria

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Inclusion Criteria

* 18-65 years old
* non-cancer neuropathic pain
* stable dose of opioids for pain
* using breakthrough pain meds
* still with persistent pain per VAS

Exclusion Criteria

* pregnant or nursing
* serious medical or psychiatric illness (including uncontrolled hypertension)
* active stomach ulcer, history or seizures or asthma
* breakthrough pain meds other than opioids
* using illicit drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dace S Svikis, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HM14748

Identifier Type: -

Identifier Source: org_study_id

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