Comparative study of Clonidine and Buprenorphine in opioid detoxification

The current study was prospective, randomized, openlabel trial to compare efficacy and tolerability of clonidine and buprenorphinein different doses in treatment of opioid dependence. 0.4mg/day and 0.8mg/daydoses of clonidine and 1.2mg/day and 2.4mg/day dose of buprenorphine werecompared. Patients of opioid dependence fulfilling the inclusion and exclusioncriteria were recruited.

In total, 100 patients were recruited in the studyand out of them, 80 patients completed the detoxification in inpatient settingfor two weeks. The patients were assessed using standard scales for variousaspects of opioid use/dependence (ASI, SOCRATES 8D, VAS, COWS, SOWS) along withsemi structured proforma for recording sociodemographic details and pattern ofopioid use. Patients were also assessed for laboratory parameters likehaemogram, serum electrolytes, renal function test, liver function test, ECG. Allpatients were screened for urine opioids at the time of admission to confirmthe active opioid use and subsequently to confirm the abstinence from illicitopioid use during study period. Patients were assessed daily for two weeksduring stay in the ward.

All groups were comparable on socio- demographicvariables except in area of occupation which showed more unemployment in highdose buprenorphine group. Patients were comparable on other opioid relatedfactors like type of opioid consumed by patients, age at first use of opioid,duration of regular use, money spent to procure opioid and addiction severityindex in various domains except legal area. Various other items of addictionseverity index and motivation level were also assessed and found werecomparable at the time of inclusion into the study.

Effectiveness of drugs in controlling withdrawalswas seen in all the groups. Buprenorphine high dose was found clearly superiorfrom all other groups on day 2 to 7 on COWS and on day 2 to 4 on SOWS incontrolling opioid withdrawals. No difference between two clonidine groups andclonidine high dose and buprenorphine low dose was seen on any scale. Low dosebuprenorphine was found to be better than low dose clonidine on day 4 only onboth the scales. High buprenorphine was found better than low dosebuprenorphine for four days (day 2, 3, 6, 7) on COWS scale only. Meanwithdrawals scores were not zero even at end of 2 weeks except in low doseclonidine group on COWS scale. No group was found better than other incontrolling craving. In all the four groups, motivation was found to besignificantly increased, especially in area of taking step.

Ancillary medicines lorazepam was used in significantlylesser doses from day 2 to 11 in high dose buprenorphine group. Majority ofpatients in both high dose groups were not requiring lorazepam by end of studyperiod. Findings are again favouring high dose buprenorphine. Oral rehydrationsolution use was least required in buprenorphine high dose group.

Adverse effects were seen more in both high dosegroups. In both clonidine groups total 4 patients developed hypotension leadingto dropout from study. Dry mouth was most common side effect in clonidine groupand constipation was most common disturbing side effect in buprenorphine group.Both drugs were well tolerated and none of the patients required dose reduction.No dropout was seen in buprenorphine group due to side effect.

To conclude, bothclonidine and buprenorphine are effective in controlling withdrawals.Buprenorphine in dose of 2.4mg/day is more effective than buprenorphine1.2mg/day and clonidine. There is no advantage in using clonidine more than0.4mg/day in controlling opioid withdrawals, rather higher dose lead to moreside effects. Clonidine has disadvantage of risk of developing hypotension evenat 0.4mg/day dose so, blood pressure monitoring and slow dose titration  is necessary.