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临床试验/CTRI/2018/11/016339
CTRI/2018/11/016339进行中(未招募)2 期

A randomised single blind sham controlled trial to evaluate the effect of transcranial direct current stimulation (tDCS) on tobacco craving among opioid dependent smokers maintained on Buprenorphine

未提供4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月12日最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
30
试验地点
4
主要终点
1) Baseline tobacco craving by Brief Questionnaire of Smoking Urges (BQSU)

研究概览

简要总结

Transcranial direct current stimulation is a non invasive neuromodulatory technique whose role is being currently explored in recent studies from western countries, among subjects with nicotine dependence to test its  effect on reducing craving to smoke and reduction in the number of cigarettes smoked.The current study is a randomised, single blind, parallel group sham controlled trial with primary objective to evaluate the effect of Transcranial direct current stimulation (tDCS) on tobacco craving among 30 opioid dependent adult male smokers who have been stabilised on Tablet Buprenorphine for opioid dependence for at least 3 months. The study will be conducted at National Drug Dependence Treatment Centre (NDDTC) and Community clinics of NDDTC. The primary outcomes that will be measured in this study are 1) Baseline tobacco craving by Brief Questionnaire of Smoking Urges and 2),. Cue induced tobacco craving by Visual Analog Scale. The secondary objectives of the study are 1) To find the effect of tDCS on cigarette/beedi consumption among opioid dependent smokers maintained on Buprenorphine maintenance for at least 3 months and 2) To find the association of socio-demographic data and clinical parameters like severity of nicotine dependence, motivation to stop smoking, etc. with change in craving and tobacco consumption due to  tDCS among opioid dependent smokers maintained on Buprenorphine maintenance for at least 3 months. Socio demographic data will be assessed using semi-structured proforma. Severity of nicotine dependence will be assessed using Fagerstrom’s test for nicotine dependence. Motivation to stop smoking will be assessed using motivation to stop scale.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Male

入选标准

  • Right handed Patients maintained on Buprenorphine for more than or equal to 3 months Current daily users of Tobacco by smoking route (Defined as Daily use of beedis or cigarettes in the past 1 month) Nicotine dependence as per ICD 10 criteria Minimum duration of Tobacco smoking is more than or equal to 1 year Smoking more than or equal to 10 cigarettes or beedis or both per day Willing to give informed consent.

排除标准

  • Current smokeless tobacco users (defined as using smokeless tobacco in past 1 month) Currently undergoing tobacco cessation treatment (in past 1 month) Current use of Benzodiazepines, Heroin, Tramadol, Dextropropoxyphene as confirmed by Urine Casette test Current alcohol harmful use or dependence (as per ICD 10 criteria based on History) Current cannabis harmful use or dependence (as per ICD 10 criteria based on History) History of significant head injury, epilepsy, major psychiatric or neurological illness (Based on history) Presence of any metallic implants or devices or metalic rods or pacemakers, etc.
  • (Based on history and physical examination) Inability to give consent (Due to Mental retardation / any illness ).

结局指标

主要结局

1) Baseline tobacco craving by Brief Questionnaire of Smoking Urges (BQSU)

时间窗: Before 1st session of tDCS | After 1st session of tDCS | After 5th session of tDCS

2) Cue induced tobacco craving by Visual Analog Scale

时间窗: Before 1st session of tDCS | After 1st session of tDCS | After 5th session of tDCS

次要结局

  • Number of beedi/cigarette consumed per day(Before 1st session of tDCS and After 5th session of tDCS)

研究者

发起方
未提供

研究点 (4)

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