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

September 21, 2005
September 24, 2008
August 2005
December 2010   (final data collection date for primary outcome measure)
Days of newborn morphine treatment [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Days of newborn morphine treatment
Complete list of historical versions of study NCT00225316 on ClinicalTrials.gov Archive Site
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 ]
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
 
Maternal Acupuncture for Substance Abuse
Can Maternal Acupuncture for Chemically Dependent Pregnant Women Reduce the Severity of Neonatal Abstinence Syndrome? - A Randomized Controlled Trial

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..

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.

Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Substance Addiction
Procedure: Acupuncture
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
180
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Female
 
Yes
Contact: Cheri Naslund 604-875-2424 ext 5372
Canada
 
NCT00225316
Dr. Patricia Janssen, University of British Columbia
W05-0041, 04-2985
University of British Columbia
 
Principal Investigator: Dr. Patricia Janssen University of British Columbia
University of British Columbia
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP