Substance AddictionPhase 3NCT00225316
Maternal Acupuncture for Substance Abuse
A Phase 3 study testing Acupuncture in people with Substance Addiction, run by University of British Columbia at 1 site in Canada.
Trial summary
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.. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Addiction
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Aug 2008
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women admitted to the chemical dependency unit at BC Women's Hospital, Vancouver, B.C.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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..
Read the 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.
- Conditions
- Substance Addiction
- Being tested
- Acupuncture
- Keywords
- RCT, intervention study, addiction, substance use, pregnancy
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of newborn morphine treatment
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AddictionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Patricia Janssen, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225316
- Sponsor's protocol ID
- W05-0041
- Other IDs
- 04-2985
- Status last verified
- May 2011
- First submitted
- 21 Sep 2005
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No