Buprenorphine and Buprenorphine/Naloxone Soluble Films for Opioid Dependence
In 2010, the Food and Drug Administration approved a soluble film formulation of sublingual buprenorphine/naloxone (B/N) for the treatment of opioid dependence. Researchers conducted a randomized controlled trial of buprenorphine soluble film and B/N soluble film in 39 active heroin users to determine their effectiveness for suppressing withdrawal symptoms during buprenorphine induction. Subjects were maintained on subcutaneous morphine for 8 days prior to randomization to standardize opioid dependence. During that time, they underwent a naloxone challenge to confirm they could exhibit measurable withdrawal symptoms. After randomization, subjects received 12 mg buprenorphine soluble film or 12 mg/3 mg B/N soluble film in 3 divided doses on day 1 followed by 16 mg buprenorphine soluble film or 16 mg/4 mg B/N soluble film on days 2–5.
- Four subjects (2 in each group) dropped out after the first dose due to inadequate control of withdrawal symptoms.
- The remaining subjects had significant decreases in Clinical Opioid Withdrawal Scale (COWS) scores on day 1 that were sustained through days 2–5.
- No significant differences in COWS scores, pupil diameter changes, or withdrawal symptoms were found between groups.
- One subject (group assignment not reported) experienced elevated liver enzymes >3 times the upper limit of normal over the 5-day course of treatment.