Baclofen versus clonidine in the treatment of opiates withdrawal, side-effects aspect: a double-blind randomized controlled trial.
OBJECTIVE
Baclofen is known for the alleviation of signs and symptoms of spasticity. Reports from our previous study have suggested that it may be at least as effective as clonidine in the management of physical symptoms of opiate withdrawal syndromes and superior to clonidine in the management of mental symptoms. We now report on a randomized double-blind comparison of baclofen vs. clonidine in view of side-effects profile.


METHODS
A total of 62 opiates addicts were randomly assigned to treatment with baclofen or clonidine during a 14-day, double-blind clinical trial. All patients met the DSM IV criteria for opioid dependence. Maximum daily doses were 40 mg for baclofen and 0.8 mg for clonidine. This trial medication was given three times per day in divided doses. The severity of side-effects was measured in days 0, 1, 2, 3, 4, 7 and 14.


RESULTS
There was no significant difference between two treat7ments in terms of retention in treatment (dropout) and overall side-effect. Nevertheless, significantly more problems relating to hypotension were encountered with subjects on clonidine.


CONCLUSIONS
We conclude that, the low incidence of hypotension with baclofen suggests that the drug may be suitable for outpatient ambulatory treatment of withdrawal from opiates.
Ahmadi-Abhari
S A
SA
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Avenue, Tehran 13334, Iran.
Akhondzadeh
S
S
Assadi
S M
SM
Shabestari
O L
OL
Farzanehgan
Z M
ZM
Kamlipour
A
A
D000328:Adult; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use; D001418:Baclofen / Q000009:adverse effects / Q000627:therapeutic use*; D003000:Clonidine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D009125:Muscle Relaxants, Central / Q000009:adverse effects / Q000627:therapeutic use; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy*
D000700:Analgesics; D009125:Muscle Relaxants, Central; D001418:Baclofen; D003000:Clonidine