Extended-release formulations of tramadol hydrochloride tramadol ER multiple brands may provide an alternative treatment option for reducing withdrawal symptoms in patients with opioid use disorder OUDnew research suggests. In a randomized study of patients with OUD, those who received tramadol ER experienced greater withdrawal suppression during a 7-day tapering phase than those who received clonidine multiple brands ; the suppression rate was about the same as those who received buprenorphine multiple brands.
In addition, the tramadol group had less severe withdrawal symptoms during the post-taper phase compared with both of the other groups. Tramadol is an "approved analgesic with opioid and nonopioid mechanisms of action and low abuse potential," write the investigators. In addition, tramadol ER, which is a Schedule V drug, "has a long elimination half-life hours that supports once-daily dosing.
Two widely used drugs for managing opioid withdrawal have been the unscheduled adrenergic agonist clonidine and the partial mu opioid agonist buprenorphine.
Although clonidine has low potential for abuse, it needs to be administered several times a day to be effective, and it has been associated with sedation and hypotension, note the researchers. Buprenorphine can be given only once daily but has abuse potential and, as a Schedule III medication, has several limitations. Some places are not willing to prescribe an opioid agonist for this type of treatment," said Dr Dunn.
The study was conducted from October to June and included a to day residential program divided into three phases. The first phase involved stabilization with mg injections of morphine four times a day for 7 to 10 days, followed by a naloxone challenge. The study cohort consisted of adults with OUD Phase two focused on tapering.
Treatment started with one oral capsule four times daily of tramadol, clonidine, or placebo plus four 2-mg sublingual tablets once daily of buprenorphine or placebo. The dosage for the tramadol group was mg on day 1 and mg on day 2. It was then tapered to mg by day 7. The clonidine group's doses were 0.
Phase three "post-taper" started on day 8. In that phase, all of the patients received placebo tablets and capsules for the remainder of the study.
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Outcome measures included withdrawal symptoms, as measured on the staff-completed Clinical Opioid Withdrawal Scale COWS and the patient-completed Subjective Opiate Withdrawal Scale SOWS ; retention; and patient requests for concomitant use of other medications during the taper or post-taper phases such as antacid or ibuprofen. Retention rates on the final taper day for the tramadol, buprenorphine, and clonidine groups were Withdrawal ratings on the COWS were ificantly different between the taper and post-taper phases for the entire patient population mean, 5.
Area under the curve analyses showed ificant mean reductions in scores on the SOWS between these two phases for the tramadol group 7.
However, withdrawal symptom scores increased slightly for the buprenorphine group 6. Between Dr Dunn noted that in a real-world setting, patients generally receive their last dose on the final taper day, "and you may not see them again; that may be their final day of treatment.
However, that effect was not seen in the patients who received tramadol ER. She noted that the are preliminary and that more research needs to be done, especially because of the current study's small sample size. But we also want to proceed with caution, and larger-scale studies with more definitive outcomes would be valuable before we categorically recommend its use. The study was funded by a grant from the National Institute on Drug Abuse.
The buprenorphine and placebo tablets were provided by Reckitt Benckiser Pharmaceuticals.
Dr Dunn has disclosed no relevant financial relationships. The original article contains a list of disclosures for coauthors.
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Deborah Brauser July 14, Dr Kelly Dunn. Commenting is limited to medical professionals.
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