A comparison of buprenorphine and lofexidine for community opiate detoxification: results from a randomized controlled trial

• Published in: Addiction (Abingdon, England) England), 2005-12, Vol.100 (12), p.1860-1867
• Main Authors: Raistrick, Duncan, West, David, Finnegan, Olwyn, Thistlethwaite, Gill, Brearley, Roger, Banbery, Jo
• Format: Article
• Language: English
• Subjects: Addiction; Addictive behaviors; Adolescent; Adult; Adult and adolescent clinical studies; Biological and medical sciences; Buprenorphine; Buprenorphine - therapeutic use; Clinical effectiveness; Clonidine - analogs & derivatives; Clonidine - therapeutic use; Community Mental Health Services - methods; Comparative analysis; Detoxification; Drug abuse; Drug addiction; Drugs; Empirical research; Female; Health; Humans; Lofexidine; Male; Medical sciences; Medical treatment; Medicine; Middle Aged; Narcotic Antagonists - therapeutic use; Narcotics; opiates; Opioid-Related Disorders - rehabilitation; Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Regression analysis; Social problems; Time series; Toxicology; Treatment; Treatment Outcome
• ISSN: 0965-2140; 1360-0443
• DOI: 10.1111/j.1360-0443.2005.01273.x

ABSTRACT Objective  To investigate whether a buprenorphine opiate detoxification regimen can be considered to be at least as clinically effective as a lofexidine regimen. Design  An open‐label randomized controlled trial (RCT) using a non‐inferiority approach. Non‐inferiority is demonstrated if, within a 95% confidence interval, buprenorphine performs within a preset tolerance limit of clinically acceptable difference in outcomes and completion rates between the two treatments. Methods  Individuals ready for heroin detoxification were given information about the trial and invited to participate. Consenting participants (n = 210) were then randomized to one of the two treatments. Detoxification was undertaken in a specialist out‐patient clinic according to predefined protocols. The primary outcome was whether or not an individual completed the detoxification. Abstinence at 1‐month follow‐up was used as a secondary outcome measure. Additional secondary outcome measures were substance use, dependence, psychological health, social satisfaction, and treatment satisfaction. Data were also collected for individuals who declined randomization and instead chose their treatment (n = 271). Results  A total of 46% of those on lofexidine and 65% of those on buprenorphine completed detoxification. Of these, 35.7% of the lofexidine and 45.9% of the buprenorphine groups reported abstinence at 1 month. Of those not completing detoxification abstinence was reported at 27.5% and 29.0%, respectively; 271 individuals who opted not to be allocated randomly and instead chose one of the two treatments produced similar results Conclusions  Buprenorphine is at least as effective as lofexidine detoxification treatment. Whether or not individuals were randomized to, or chose, a treatment appeared not to affect the study's outcome.