Condition category
Mental and Behavioural Disorders
Date applied
09/09/2005
Date assigned
20/01/2006
Last edited
24/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 Women’s 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

http://www.sickkids.ca

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

  1. 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.

Additional files

Editorial Notes