This study will obtain pilot data on the acceptability of a 12-week course of daily observed Suboxone and methadone, followed by a dose taper or referral to a local treatment program for 80 opioid dependent patients (40/group) who have been injecting Subutex or other buprenorphine preparations 10 or more days in the past 30, and on the impact of each medication on HIV risk and on Subutex and opioid use during treatment and a followup at week 20. It will be done at the Uranti Methadone Program, affiliated with the Addiction Research Center, Union Alternative Georgia in Tbilisi. Unlike Ukraine and Russia where the prevalence of HIV among IDUs is 40-50%, the prevalence among IDUs in Georgia is 10-15% even though hepatitis C is found in 50% or more. This low prevalence of HIV is not likely to continue unless there is an expansion in HIV prevention that includes substance abuse treatment. A problem found in Georgia and a few other countries is that approximately half the persons addicted to opioids are injecting buprenorphine, mostly Subutex that is smuggled into the country from Western Europe. There are no data on how to treat these patients or how to best reduce their HIV risk, which is the focus of this proposal. This study builds on a relationship established with the Georgian P.I. David Otiashvili, MD, and with Gvantsa Piralishvili, M.D., PhD, who works with Dr. Otiashvili and is currently a NIDA/CTN Invest fellow mentored by Dr. Woody and colleagues at Penn and the Delaware Valley Node of the CTN since her arrival in 4/08. The focus of her fellowship is learning how to study outcome from methadone and Suboxone treatment and their impact on HIV risk behavior for when she returns to Tbilisi in 4/09. Though buprenorphine injecting is not unique to Georgia, Georgia is a unique setting to obtain pilot data on how to treat it because the concentration of buprenorphine injectors is high, there are waiting lists for agonist treatment, and patient recruitment should not be a problem. The primary aims of this pilot study are thus to: 1) Obtain pilot data on the impact of a 12-week course of daily, observed Suboxone and methadone treatment on HIV injecting risk behavior, particularly that associated with injecting use of Subutex 2) Obtain pilot data on the degree to which the target population accepts treatment with daily observed Suboxone and methadone
This study will obtain pilot data on the acceptability of a 12-week course of daily observed Suboxone and methadone on 80 opioid dependent patients (40/group) who have been injecting Subutex or other buprenorphine preparations for 15 or more days in the past 30, and of the impact of each medication on HIV risk and opioid use during treatment and at followup. It will be done at the Uranti Methadone Program, affiliated with the Addiction Research Center, Union Alternative Georgia in Tbilisi, Republic of Georgia where the prevalence of HIV is relatively low, but where HIV risk is high in association with injecting Subutex and other buprenorphine preparations by approximately half of the opioid dependent patients.
|Piralishvili, Gvantsa; Otiashvili, David; Sikharulidze, Zura et al. (2015) Opioid addicted buprenorphine injectors: drug use during and after 12-weeks of buprenorphine-naloxone or methadone in the Republic of Georgia. J Subst Abuse Treat 50:32-7|
|Otiashvili, David; Piralishvili, Gvantsa; Sikharulidze, Zura et al. (2013) Methadone and buprenorphine-naloxone are effective in reducing illicit buprenorphine and other opioid use, and reducing HIV risk behavior--outcomes of a randomized trial. Drug Alcohol Depend 133:376-82|
|Pecoraro, Anna; Fishman, Marc; Ma, Michelle et al. (2013) Pharmacologically assisted treatment of opioid-dependent youth. Paediatr Drugs 15:449-58|