I was discussing this question recently with a colleague who pointed me to:
J Subst Abuse Treat. 2003 Jun;24(4):363-7.
Is opiate detoxification unsafe in pregnancy?
Luty J, Nikolaou V, Bearn J.
PMID: 12867211
This group in London treated 101 pregnant women for opiate withdrawal with a 21 day methadone taper. This was a retrospective case series of all admissions from 1988 to 1999.
They noted 1 miscarrage out of 5 women in the 1st trimester, at 9 weeks gestation. The authors estimated with this tiny sample that the relative risk for miscarriage was 6.87 "compared to population norms."
There were no adverse events noted for the 54 women in the 2nd trimester.
There was one preterm delivery in the remaining women who were in 3rd trimester. The authors believe this was within "population norms". There is no comment about the gestational age or the baby's weight. The authors state this was out of 57 "treatment episodes" suggesting several women were seen for more than one attempt.
Of the 101 women who started the detoxification treatment, only 42 completed and only 8 were discharged to residential rehabilitation.
The authors tracked down delivery records for 28 women, out of 50 women who delivered in the 3 large obstetric centers associated with the study. Mean weight at delivery was 2564 g (5 lbs 10 oz) with 7 babies less than 2500 grams. Mean gestational age was 37.5 week. None of these 28 women had entered a rehab program after discharge from the detox. Of the 28 only 10 women had in fact completed the detox procedure and only 1 was abstinent at the time of delivery.
What can we conclude from this study?
A 21 day inpatient taper of methadone had dismal results. Of the original 101 patients, only 42 women remained in treatment until the time of discharge. Only 8 were discharged to residential treatment. One of 5 first trimester women miscarried during the procedure. One of 57 third trimester women delivered early during the procedure although the birth weight and gestational age is not given.
Of the small sample who's birth records they reviewed, the average birth weight was 5 lbs 10 oz and gestational age 37.5 weeks. Seven of the 28 babies were below 2500g. Only one woman was abstinent at the time of delivery.
The authors conclude "Methadone detoxification treatment was not associated with any increased risk of miscarriage in the second trimester or premature delivery in the third trimester." but it would be more reasonable to note that in this study methadone detoxification was not effective in promoting sobriety or abstinence and lead to poor birth weights.
Sunday, September 16, 2012
More on baclofen for alcholism
I posted about this back in June but there is some new info about baclofen for alcohol dependence.
Abstinence and 'Low-Risk' Consumption 1 Year After the Initiation of High-Dose Baclofen
A Retrospective Study Among ‘High-Risk’ Drinkers
Laurent Rigal; Constance Alexandre-Dubroeucq; Renaud de Beaurepaire; Claire Le Jeunne; Philippe Jaury
Alcohol Alcohol. 2012;47(4):439-42. © 2012 Oxford University Press
This is a retrospective study of 181 patients, each 12 months after beginning high dose baclofen for alcohol dependence. The average dose was 145 mg per day (min = 30, max = 400) much higher than the 10 mg TID seen in other studies. Patients were gradually titrated upward "progressively (steps of 15 mg/week, then 30 if possible, according to tolerance) until it abolished craving, to the extent possible".
Of the original 181 patients, 132 were still available for follow up at 12 months. 78 patients were abstinent, 28 were drinking at low levels, which leaves 26 still drinking heavily. If we assume the patients lost to follow up were also drinking heavily (worst case scenario) then of the original cohort 43% were abstinent, 15% had mild alcohol use and 41% continued to drink heavily.
The average alcohol use at the start of the study was 182 grams per day, 13 standard drinks per day in the USA. Low risk drinking was defined as less than 40 grams daily, less than 3 standard drinks.
86% had some adverse effect, usually transient, during dose increases, and sometimes while drinking alcohol. Baclofen increased somnolence and confusion induced by alcohol, as we would expect for a GABA drug. Only six patients stopped their treatment . Only 6 of the patients stated that they stopped the medication due to adverse effects.
It is noted that the authors did not confirm alcohol use or abstinence by family reports or by biological testing.
The authors are very supportive of reduced drinking, short of abstinence, as a therapeutic goal.
At least some more doctors in France are offering very high dose baclofen for alcoholism. The overall sobriety rate of 43% and 15% drinking less is hopeful but not incredibly impressive. Since this wasn't a controlled trial we can't speak to whether the benefit was due to the medication itself or placebo effect or provider support or even regression to the mean as the authors point out.
There are risks to baclofen, perhaps less in the using than in the stopping. This GABA-B agonist can have it's own withdrawal, similar to benzodiazepine or alcohol withdrawal although the incidence may be less often.
This study at least suggests, that if we do want to try baclofen to help a patient quit drinking, ongoing alcohol use or cravings might be treated with increasing dose to high levels rather than abandoning the effort.
The average alcohol use at the start of the study was 182 grams per day, 13 standard drinks per day in the USA. Low risk drinking was defined as less than 40 grams daily, less than 3 standard drinks.
86% had some adverse effect, usually transient, during dose increases, and sometimes while drinking alcohol. Baclofen increased somnolence and confusion induced by alcohol, as we would expect for a GABA drug. Only six patients stopped their treatment . Only 6 of the patients stated that they stopped the medication due to adverse effects.
It is noted that the authors did not confirm alcohol use or abstinence by family reports or by biological testing.
The authors are very supportive of reduced drinking, short of abstinence, as a therapeutic goal.
This study also renews the questions about abstinence. A reduction in craving allowed some patients to advance towards abstinence and to maintain this state without having to experience the personal hardships of detoxification (Ameisen, 2008). This change is likely to modify the individual's experience of treatment by limiting the usual feelings of guilt and failure. Abstinence is neither a preliminary requirement nor an objective that can be met only in pain. And, if some patients succeed in maintaining moderate consumption, should we not prefer consumption at low risk to abstinence as the principal endpoint of trials (European Medicines Agency, 2010)?What does this mean?
At least some more doctors in France are offering very high dose baclofen for alcoholism. The overall sobriety rate of 43% and 15% drinking less is hopeful but not incredibly impressive. Since this wasn't a controlled trial we can't speak to whether the benefit was due to the medication itself or placebo effect or provider support or even regression to the mean as the authors point out.
There are risks to baclofen, perhaps less in the using than in the stopping. This GABA-B agonist can have it's own withdrawal, similar to benzodiazepine or alcohol withdrawal although the incidence may be less often.
This study at least suggests, that if we do want to try baclofen to help a patient quit drinking, ongoing alcohol use or cravings might be treated with increasing dose to high levels rather than abandoning the effort.
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