Opioid antagonist detoxification under anaesthesia versus traditional clonidine detoxification combined with an additional week of psychosocial support: a randomised clinical trial.
BACKGROUND
While detoxification under anaesthesia accelerates the detoxification procedure, there is a lack of randomised clinical trials evaluating its effectiveness compared to traditional detoxification procedures, and a lack of data on long-term abstinence.


METHODS
Prospective randomised clinical trial. Analysis by intention to treat and per protocol.


METHODS
Specialised substance abuse unit in a psychiatric teaching hospital and an intensive care unit of a general hospital.


METHODS
Seventy patients with opiate mono-dependence requesting detoxification: 36 randomised to RODA (treatment as allocated received by 26) and 34 randomised to classical clonidine detoxification (treatment as allocated received by 21).


METHODS
Successful detoxification, safety and self-reported abstinence at 3, 6 and 12 months after detoxification.


RESULTS
Socio-demographics were similar in both groups at baseline. No complications were reported during or after anaesthesia. According to the intention to treat analysis, 28/36 (78%) RODA patients and 21/34 (62%) of the clonidine group successfully completed the detoxification process (p=0.14). In the intention to treat analysis, 30% of RODA patients were abstinent after 3 months compared to 14% in the clonidine group (p=0.11). No difference was found at 6 and 12 months (both groups showed less than 5% abstinence after 12 months). The per-protocol analysis showed similar results with no statistical differences either for ASI mean scores or for the SF36 questionnaire.


CONCLUSIONS
Although the detoxification success rate and abstinence after 3 months were slightly better for the RODA procedure compared to clonidine treatment, these differences were not statistically significant and disappeared completely after 6 and 12 months.
Favrat
B
B
Substance Abuse Division, Department of Psychiatry, University of Lausanne, Medical Outpatient Clinic, Bugnon 44, 1011 Lausanne, Vaud, Switzerland. Bernard.Favrat@hospvd.ch
Zimmermann
G
G
Zullino
D
D
Krenz
S
S
Dorogy
F
F
Muller
J
J
Zwahlen
A
A
Broers
B
B
Besson
J
J
D000328:Adult; D000465:Algorithms; D000700:Analgesics / Q000627:therapeutic use*; D000768:Anesthesia, General; D003000:Clonidine / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006556:Heroin Dependence / Q000188:drug therapy* / Q000523:psychology*; D006778:Hospitals, Psychiatric; D006784:Hospitals, Teaching; D006801:Humans; D008658:Inactivation, Metabolic; D008297:Male; D009271:Naltrexone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D011446:Prospective Studies; D012008:Recurrence; D013375:Substance Withdrawal Syndrome / Q000523:psychology*; D013997:Time Factors; D016896:Treatment Outcome
D000700:Analgesics; D009292:Narcotic Antagonists; D009271:Naltrexone; D003000:Clonidine