Adam Bisaga, MD
Dr. Adam Bisaga is a Professor of Psychiatry at the Columbia University Irving Medical Center and a Research Scientist at the New York State Psychiatric Institute.
Dr. Bisaga received his medical degree from Jagiellonian University Medical College in Krakow, Poland. He completed his psychiatric residency at the North Shore University Hospital in Manhasset, NY and his addiction psychiatry fellowship at the Division of Substance Abuse at Columbia University. Here he received training in addiction psychiatry research under the mentorship of Drs. Marian Fischman and Herbert Kleber. Dr. Bisaga became a faculty at the Department of Psychiatry in 1999 and he was promoted to the rank of Professor in 2012.
Dr. Bisaga received a Career Development Award in 1999 and has since been continuously funded by the National Institute of Drug Abuse (NIDA) to conduct research focusing on development of new medication strategies to treat substance use disorders. His recent work has focused on opioid use disorder with the goal of improving outcome of treatment with long-acting naltrexone.
In addition to his research, Dr. Bisaga has been involved in training and mentoring of medical students, trainees and medical providers locally, nationally, and internationally. This includes co-directing the SAMHSA-funded national training and mentoring program “Providers’ Clinical Support System (PCSS)” aiming to expand and improve treatment for opioid use disorder.
Dr. Bisaga has been involved in public health projects with NYS Office of Alcoholism and Substance Abuse Services (OASAS) and in the NYC Department of Health. At the national level he testified in Congressional hearings on combatting the opioid epidemic and participated in the hearings of the National Academy of Sciences.
Dr. Bisaga is a member of UN Expert Panel and the UN Office of Drugs and Crime International Scientific Network. He conducted trainings and addiction treatment program developments internationally and he contributed to development of UN/WHO substance abuse treatment standards and guidelines and several training programs.
Areas of Expertise / Conditions Treated
- Addiction Psychiatry
- Opiate Pharmacology
- Substance Use
- Professor of Psychiatry at CUMC
- NewYork-Presbyterian / Columbia University Irving Medical Center
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Credentials & Experience
Education & Training
- Copernicus Academy of Medicine
- Jagiellonian University Medical College
- Residency: North Shore University Hospital
- Fellowship: New York State Psychiatric Institute
- Addiction Psychiatry
Honors & Awards
Castle and Connoly Top Doctor in Addiction Psychiatry (2012, 2013).
Dr. Bisaga is currently overseeing three research projects focusing on developing novel medication interventions for individuals with Opioid Use Disorder (OUD). New treatment approaches are needed to help address the epidemic of opioid overdose deaths in the US.
Evaluation of Safety and Pharmacokinetics of Naltrexone Implant
Currently available medications to treat OUD are highly efficacious, but their effectiveness in practice is limited by poor adherence, with many patients stopping treatment prematurely and relapsing. Currently available formulation of extended-release (XR) naltrexone provides sufficient amount of medication to last up to 1 month after a single injection. However, up to 50% of patients started on XR-naltrexone discontinue treatment in the first 6-months, and this limits its effectiveness for long term OUD treatment and overdose prevention
The goal of this study is to develop an innovative long acting subcutaneous implanted formulation of naltrexone, the O’Neil Long-Acting Naltrexone Implant (OLANI), with the goal of FDA approval. OLANI is expected to produce therapeutic naltrexone blood levels for 6 months after implant circumventing the need for adherence to monthly XR-naltrexone injections while protecting against the relapse.
OLANI is a biodegradable implant that gradually dissolves releasing naltrexone for many months after the insertion. OLANI is inserted under the skin on the abdomen using a minor surgical procedure under a local anesthesia. This naltrexone implant has been developed and used in Australia for 20 years with several prototypes evaluated in controlled clinical trials and used clinically. The current OLANI formulation has been used clinically in over 800 patients, giving confidence that the product can be successfully developed in the US.
In the current study we evaluate the safety and the duration of naltrexone release from OLANI in a diverse group of healthy volunteers that are monitored for up to 18 months after the implantation. In the fall of 2020, we expect to begin the recruitment of participants with OUD seeking relapse prevention with naltrexone after completing detoxification. Over the 12-month study they will receive two OLANI administrations, in addition to medical and psychological treatment, while naltrexone blood level and clinical outcomes are being monitored. If OLANI is shown to provide a safe, feasible and effective method of delivery of naltrexone at therapeutic levels for at least 6 months, it would represent a major advance in the field of OUD treatment providing effective long-term relapse-prevention treatment to individuals that have undertaken opioid detoxification.
Improving the Real-World Effectiveness of Injection Naltrexone for Opioid Use Disorder (SWIFT-CTN0097)
Extended-release naltrexone (XR-naltrexone) is a medication administered monthly by injection approved by the FDA for the relapse prevention treatment after detoxification in patients with opioid use disorder (OUD). However, XR-naltrexone remains under-utilized because of the difficulty initiating this medication in patients presenting for treatment with active opioid use. Starting naltrexone requires a 4-5 day long detoxification and 7-10 day wait-period to assure that the first injection is well tolerated. However, this involves patients tolerating protracted opioid withdrawal symptoms and a substantial delay carrying the risk of dropout and relapse. Shorter methods that last 5-7 days minimize the drop-out rate during the wait period and increase the induction success rate. These “rapid” protocols have been developed but have been rarely used in practice.
This multi-center study conducted at six community treatment programs around the country compares the novel rapid procedure for initiating treatment with XR-NTX with the standard procedure that requires a long wait period. In the course of this study we will develop a training package and the implementation strategy that can support widespread adoption of rapid XR-naltrexone initiation across inpatients and residential treatment facilities.
A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders
Buprenorphine is the primary medication used in the community for treatment of OUD. Buprenorphine is effective for approximately 50-70% of patients and better results are achieved with the longer duration of treatment. However, the prospect of long-term opioid maintenance is not acceptable to some patients and they eventually request to stop treatment or discontinue it on their own. As many patients who had good treatment response desire to discontinue buprenorphine there is a need to collect evidence about the best strategy to accomplish discontinuation while minimizing the risk of relapse following it.
We suggest that naltrexone may be used for patients who wish to discontinue buprenorphine maintenance and be protected from relapse and we are conducting an open-label randomized outpatient trial to evaluate feasibility and efficacy of rapid BUP discontinuation followed by brief course of treatment with XR-naltrexone and to compare it to the standard method of gradual BUP taper. Individuals with OUD (N=55) who have successfully completed at least 6 months of buprenorphine treatment and do not wish to remain in a long-term buprenorphine maintenance program are recruited. The first treatment phase includes a 4-week period of stabilization on buprenorphine 4-8 mg followed by randomization to: 1) buprenorphine discontinuation and rapid outpatient transition to XR-naltrexone with 3 monthly injections, or 2) buprenorphine discontinuation using a gradual, 5-week long taper. In both groups participants receive weekly relapse prevention therapy and are monitored for the duration of the trial, which is 6 months post randomization.
We hypothesize that more patients will successfully discontinue buprenorphine long-term in the group that received XR-naltrexone. A positive signal that transition from maintenance buprenorphine to XR-naltrexone is feasible and prevents relapse would encourage a larger trial to replicate and perhaps extend to multiple community-based treatment settings. A feasible, well-tolerated, and effective method of helping patients wishing to discontinue treatment with buprenorphine has the potential to expand the population of opioid--dependent individuals benefitting from treatment.
- Addiction Psychiatry
Selected Recent Publications
- Bisaga A, Sullivan MA, Glass A, Mishlen K, Carpenter KM, Mariani JJ, Levin FR, Nunes EV. A placebo-controlled trial of memantine as an adjunct to injectable extended-release naltrexone for opioid dependence. J Subst Abuse Treat. 2014, 46:546-52.
- Bisaga A, Sullivan MA, Glass A, Mishlen K, Pavlicova M, Haney M, Raby WN, Levin FR, Carpenter KM, Mariani JJ, Nunes EV. The effects of dronabinol during detoxification and the initiation of treatment with extended release naltrexone. Drug Alcohol Depend, 2015, 154, 38-45.
- Williams AR, Bisaga A. From AIDS to Opioids - How to Combat an Epidemic. N Engl J Med. 2016, 375, 813-815.
- Sullivan MA, Bisaga A, Pavlicova M, Carpenter KM, Mariani JJ, Levin FR, Nunes EV. Long-acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification with Naltrexone vs. Buprenorphine. Am J Psychiatry. 2017, 174, 459-467.
- Bisaga A, Mannelli P, Yu M, Nangia N, Graham CE, Tompkins DA, Kosten TR, Akerman SC, Silverman BL, Sullivan MA. Outpatient transition to extended-release injectable naltrexone for patients with opioid use disorder: a phase 3 randomized trial. Drug Alcohol Depend. 2018, 187, 171-178.
- Bisaga A, Mannelli P, Sullivan MA. Vosburg SK, Compton P, Woody GE, Kosten TR. Antagonists in the Medical Management of Opioid Use Disorders: Historical and Existing Treatment Strategies. Am J Addict. 2018, 27, 177-187.
- Sullivan AM, Bisaga A, Pavlicova M, Carpenter K, Choi CJ, Mishlen K, Levin FR, Mariani JJ. Nunes EV. A randomized trial comparing extended-release injectable suspension and oral naltrexone, both combined with behavioral therapy, for the treatment of opioid use disorder. Am J Psychiatry. 2019 Feb 1;176(2):129-137.
- Bisaga A. What should clinicians do as fentanyl replaces heroin. Addiction. 2019, Jan 20.
- Nunes EV, Bisaga A, Krupitsky E, Nangia N, Silverman BL, Akerman SC, Sullivan MA. Opioid use and dropout from extended-release naltrexone in a controlled trial: Implications for mechanism. Addiction. 2019 June 13.
- Sibai M, Mishlen K, Nunes EV, Mariani JJ, Bisaga A. A week-long outpatient induction onto XR-naltrexone in patients with opioid use disorder. Am J. Drug Alcohol Abuse. 2019, Dec 20:1-8.
- Bisaga A with Chernyaev K. Overcoming Opioid Addiction. The authoritative medical guide for patients, families, doctors, and therapist. The Experiment, 2018.