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Maternal Acupuncture for Substance Abuse
This study is currently recruiting participants.
Verified by University of British Columbia, September 2008
First Received: September 21, 2005   Last Updated: September 24, 2008   History of Changes
Sponsored by: University of British Columbia
Information provided by: University of British Columbia
ClinicalTrials.gov Identifier: NCT00225316
  Purpose

To determine the efficacy of daily maternal acupuncture treatments in reducing the frequency and severity of neonatal abstinence syndrome among infants born to substance-using women..


Condition Intervention Phase
Substance Addiction
Procedure: Acupuncture
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Can Maternal Acupuncture for Chemically Dependent Pregnant Women Reduce the Severity of Neonatal Abstinence Syndrome? - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Days of newborn morphine treatment [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gestational age at birth, rates of intrauterine growth restriction, days to regain birthweight, rates of admission to a level II or level III nursery and length of stay, and rates of apprehension of the infant by the Ministry of Children and Families [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: August 2005
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Acupuncture
    See Detailed Description.
Detailed Description:

Potential study subjects will be recruited from the Chemical Dependency Unit by a trial coordinator. After obtaining written informed consent, the coordinator will take a sequentially numbered opaque envelope from a box on the unit. This envelope will contain a card indicating the treatment group to which the woman is allocated. Women participating in the treatment group of our study will have access to a quiet room furnished with comfortable reclining chairs. The acupuncturist will swab the ears with alcohol and insert sterile, disposable needles. Following the treatment, which is 45-minutes in length, participants will remove the needles themselves and place them in protective sharps boxes. A sham acupuncture procedure will not be used. Chinese traditional medicine does not include the concept of a placebo. Those who argue that auricular acupuncture stimulates the vagus nerve, which innervates the ear concha state that needles placed anywhere in the concha should produce the same effects. 58 Studies utilizing sham procedures have failed to show a difference between the control and active experimental conditions.

In this unit, morphine is prescribed for the neonate by pediatricians (11 in total) if there is a constellation of symptoms unresponsive to environmental control including: 1) convulsions, 2) inconsolability or crying continuously for 3 hours, 3) persistent tremors or jitteriness when undisturbed, 4) continuous central nervous system irritability including hyperactive Moro reflex, tremors, jitteriness, increased muscle tone and unprovoked muscle jerks, 5) persistent vomiting or projectile vomiting over a 12 hour period; or 6) explosive diarrhea for 2-3 consecutive episodes.

Additional clinical signs such as tachycardia, tachypnea, watery stools, fever, or weight loss > 10% may justify use of morphine after consideration of differential diagnoses. Morphine 1mg/ml is started at a rate of 0.03 mg/kg/dose every 3 hours. The dose is reviewed daily and titrated based on daily weights and ongoing symptoms.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Women admitted to the chemical dependency unit at BC Women's Hospital, Vancouver, B.C.

Exclusion Criteria:

  • Women who neither read nor write English
  • Having a pacemaker or any other electrical implants
  • Bleeding disorder or on anti-coagulants
  • Conditions putting someone at particular risk for infection including damaged heart valves or prior heart valve surgery, history of myocardiopathy, diabetes requiring insulin, history of knee or hip replacements, immunosuppressive drug therapy, open wounds.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225316

Contacts
Contact: Cheri Naslund 604-875-2424 ext 5372

Locations
Canada, British Columbia
BC Women's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3N1
Contact: Cheri Naslund     604-875-2424 ext 5372        
Principal Investigator: Patricia Janssen, PhD            
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Dr. Patricia Janssen University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia ( Dr. Patricia Janssen )
Study ID Numbers: W05-0041, 04-2985
Study First Received: September 21, 2005
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00225316     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
RCT
intervention study
addiction
substance use
pregnancy

Study placed in the following topic categories:
Behavior, Addictive
Mental Disorders
Neonatal Abstinence Syndrome
Substance-Related Disorders
Disorders of Environmental Origin
Infant, Newborn, Diseases

Additional relevant MeSH terms:
Mental Disorders
Neonatal Abstinence Syndrome
Substance-Related Disorders
Disorders of Environmental Origin
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 06, 2009