Effects of deep rTMS as an add on therapy on Neurophysiological, Cognitive and Clinical outcomes in patients with opioid dependence
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- NIMHANS
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Craving score (using VAS scale)
研究概览
简要总结
Opioids are extensively used in medical practice, primarily for their potent analgesic properties in managing pain. Due to their ability to provide profound pain relief, opioids are commonly administered as anesthetic agents during and after surgery for effective pain management. opioids exert their effects by binding to specific opioid receptors that are found throughout central nervous system and peripheral tissues. When these receptors are activated, they trigger the release of dopamine in the nucleus accumbens, a key brain region involved in the processing of reward and pleasure. This surge in dopamine leads to intense feelings of euphoria and reinforces the behavior of substance use, making it more difficult for individuals to resist further consumption. Medications like buprenorphine, naltrexone, and methadone are commonly used to treat opioid dependence and have shown promising results.
Despite the medication-assisted treatment and behavioral interventions, sustained recovery remains a challenge due to the chronic relapsing nature of this disorder. There is a persistent high relapse rate ranging from 40 percent to 77 percent within the first six months of treatment. These troubling statistics highlight the need for novel therapeutic strategies to overcome the limitations of current treatment methods.
In the current study, we aim to administer Deep rTMS as an add-on therapy in opioid dependence using H4 coil targeting bilateral PFC and insula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- All
入选标准
- •Opioid use disorder patients (diagnosed by DSM-V criteria) o Age: 18 – 45 years o Either gender o Right-handed o Normal / Corrected to normal vision o Written informed consent o Clinical Opiate Withdrawal Scale (COW) score of 0 o Education: ability to read and write.
排除标准
- •o History of any other psychiatric disorders o Any neurological disorders including epilepsy o Any other known systemic disorders o Presence of any metal implants in head.
结局指标
主要结局
Craving score (using VAS scale)
时间窗: Craving score (using VAS scale)
次要结局
- Scales/questionnaires, EEG functional connectivity and cognitive task measures, TMS excitability measures, HRV(Baseline (DAY 0); Post-intervention (Day5))
研究者
Dr TN Sathyaprabha
NIMHANS
