Contact information
Type
Scientific
Primary contact
Dr Patricia Janssen
ORCID ID
Contact details
University of British Columbia (UBC) Dept of Health Care and Epidemiology
5804 Fairvew Ave
Vancouver
V6T-1Z3
Canada
+1 604 875 2424, local 5414
pjanssen@interchange.ubc.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CAM 05-325
Study information
Scientific title
Acronym
Study hypothesis
Infants whose mothers have been randomized to receive standard care (methadone maintenance) in combination with daily acupuncture treatments versus standard care alone will require fewer days of treatment with morphine for neonatal abstinence syndrome.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Drug addiction
Intervention
Acupuncture using National Acupuncture Detoxification Association (NADA) protocol + standard care versus standard care alone.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Days of neonatal morphine treatment
Secondary outcome measures
1. Gestational age at birth
2. Rates of intrauterine growth restriction
3. Scores on the Neonatal Abstinence Syndrome Scale
4. Rates of admission to a level II or level III nursery and length of stay
5. Days to regain birthweight
6. Rates of apprehension by the Ministry of Children and Families prior to discharge from hospital
Overall trial start date
01/08/2005
Overall trial end date
01/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
All women admitted to the Chemical Dependency Unit at BC Womens Hospital will be offered participation.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
180
Participant exclusion criteria
Women who can neither read nor write English.
Recruitment start date
01/08/2005
Recruitment end date
01/08/2007
Locations
Countries of recruitment
Canada
Trial participating centre
University of British Columbia (UBC) Dept of Health Care and Epidemiology
Vancouver
V6T-1Z3
Canada
Sponsor information
Organisation
Toronto SickKids Foundation (Canada)
Sponsor details
555 University Avenue
Toronto
M5G-1X6
Canada
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Toronto Sickkids Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23259913
Publication citations
-
Results
Janssen PA, Demorest LC, Kelly A, Thiessen P, Abrahams R, Auricular acupuncture for chemically dependent pregnant women: a randomized controlled trial of the NADA protocol., Subst Abuse Treat Prev Policy, 2012, 7, 48, doi: 10.1186/1747-597X-7-48.