Deep Brain Stimulation for Refractory Alcoholism
- Current treatments for alcoholism have limited success. More than half of people with alcoholism return to uncontrolled drinking even after treatment or self-help programs. One possible treatment is the use of deep brain stimulation (DBS). DBS studies of the ventral capsule/ventral striatum, a region of the brain, reduced cravings for alcohol in a small group of alcoholics. DBS is approved for treating other disorders, such as Parkinson s disease, but not for treating alcoholism. Researchers want to study whether DBS can be used to treat chronic alcoholism.
- To see if deep brain stimulation is helpful and safe for people who have chronic alcoholism.
- Individuals between 21 and 60 years of age who have been diagnosed with chronic alcoholism.
- Participants must have tried for more than 10 years to stop drinking alcohol, and have failed multiple treatment and self-help programs. They may not have any other current substance abuse or dependence problem (except alcohol and nicotine).
- Participants will start the study by entering a separate alcohol detoxification study at the National Institutes of Health. They will be monitored during this study with blood tests and brain scans.
- Participants will have 2 weeks of baseline tests. They will include physical exams and blood and urine tests. They will also include tests of thinking and memory, and questions about current moods.
- Participants will have surgery to insert the DBS device. Electrodes will be placed in the brain and a battery pack will be placed in the chest. Participants will recover from the surgery and continue the alcohol detoxification program.
- About 4 weeks after surgery, participants will be separated into two groups. For one group, the DBS device will be turned on with electrical stimulation and participants will be monitored for an additional two weeks in the hospital to find the right setting for the device. For the second group, participants will receive mock stimulation, but no real electrical DBS, and will also be monitored for an additional two weeks in the hospital.
- Participants will return home for 24 weeks. During this time they will have frequent study visits to look at the DBS device. These visits will include questions about mood and memory, as well as imaging studies.
- All participants will return for an additional two week inpatient stay in the hospital. Those participant who had initially received mock stimulation will now have their devices turned on with real electrical stimulation and will be monitored for the two weeks to find the right setting for the device. Those participants who had initially received real stimulation will continue to receive stimulation while being monitored for the two weeks.
- Participants will return home for another 24. All participants at this point will have actual electrical DBS. Participants will continue to have frequent study visits for up to a year to look at the DBS device. These visits will also include questions about mood levels and alcohol cravings.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Pilot Study of Deep Brain Stimulation (DBS) for Refractory Alcoholism|
- Test safety of DBS of the nucleus accumbens, ventral striatum and ventral capsule in patients with treatment-resistant alcoholism. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||September 2021|
|Estimated Primary Completion Date:||September 2021 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01798888
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Kareem A Zaghloul, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|