In the first clinical trial of a medication that was used for an extended time to treat opioid addiction in young adults, participants who received counseling and Suboxone (buprenorphine-naloxone) for 12 weeks had substantially better outcomes than those who received the standard treatment of short-term detoxification and counseling.
The study, published November 5 in the Journal of the American Medical Association, was conducted through the National Drug Abuse Treatment Clinical Trials Network supported by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). Opioids include heroin, morphine and prescription pain killers such as Vicodin and Oxycontin.
Opioid-addicted youth who continued to take Suboxone for 12 weeks were less likely to use opioids, cocaine and marijuana, to inject drugs, or drop out of treatment than those who received short-term detoxification and counseling.
"These findings should reassure and encourage providers who have been hesitant to offer extended Suboxone treatment to this population," said NIDA Director Dr. Nora Volkow. "They also highlight the need for longer-term studies to determine whether sustained treatment can improve outcomes."
Suboxone is a medication containing buprenorphine and naloxone, combined in a single tablet. Buprenorphine - which has been used successfully as a treatment for heroin addiction - works by acting on the brain's opiate receptors to relieve withdrawal and cravings without prompting the same intense high or dangerous side effects as other opioids. When combined with naloxone, buprenorphine's abuse potential is further limited because people who try to inject it experience severe withdrawal symptoms. However, when Suboxone is taken orally, as prescribed, these adverse effects do not occur.
For this study, investigators recruited 154 opioid-addicted patients aged 15 to 21 at six outpatient substance abuse treatment clinics around the country. Patients had been addicted to opioids for an average of 1.5 years. All participants were offered group and individual counseling for 12 weeks. In addition, participants were randomly assigned to either 2 weeks of detoxification using Suboxone or 12 weeks of extended Suboxone treatment. In the latter group, the daily dose of Suboxone was gradually tapered downward starting at week 9 and the drug was discontinued at week 12.
Participants assigned to extended Suboxone treatment were much less likely to provide opioid-positive urine samples at weeks 4 and 8, but not at week 12 (when the dose had tapered off) than those in the standard detoxification group. Follow-up evaluations at months 6, 9 and 12 showed increased rates of opioid use in both groups compared to the end of the treatment period; however, rates of opioid use were somewhat lower in both groups than they were before treatment, particularly in the extended-treatment group. Although patients were young, findings resembled those of older adults with longer term opioid dependence.
"We saw a marked reduction in opioid and other drug use; less injecting behavior, and better treatment retention in the patients assigned to longer-term Suboxone treatment," says principal investigator George Woody, M.D., of the University of Pennsylvania and Treatment Research Institute, and VA Medical Center in Philadelphia.
"Extended use of Suboxone appeared to effectively control study participants' symptoms of opioid withdrawal," says co-investigator Geetha Subramaniam, M.D., of Johns Hopkins University, who oversaw patients enrolled in the study at a substance abuse treatment clinic in Baltimore. "The teens and young adults readily accepted Suboxone and tolerated it well. They seldom complained about sedation [a side effect of methadone and other medications for opioid dependence] and were pleased that they remained alert and could function during the day."
Buprenorphine is listed as a Schedule III controlled drug by the U.S. Drug Enforcement Administration. It is considered to have less risk of causing dependence than Schedule II drugs such as methadone, morphine, and oxycodone. Subutex (buprenorphine) and Suboxone are the first medications available for the treatment of opioid dependence that can be prescribed in a doctor's office by specially trained and licensed physicians. Suboxone was approved by the U.S. Food and Drug Administration in 2002 for the treatment of opioid dependence.