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临床试验/NCT03557632
NCT03557632Unknown不适用

University of Houston Drug Abuse Research Development Program II

University of Houston2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Self-reported reactivity to cues

研究概览

简要总结

The study is examining the impact of a Virtual Reality Cue Exposure Therapy intervention on heroin cravings compared to Relapse Prevention Drug Education.

详细描述

Injection Drug Use (IDU) is a chronic, relapsing condition with grave individual and public health consequences.19-21 A majority (53%) of all past-year IDUs prefer heroin, as do 39% of single-drug injectors, second only to Methamphetamine.22,23 Non-injection heroin use (NIDU) is increasing, due to growing awareness of IDU risks, particularly HIV/AIDS;21,24-26 increased purity of street heroin;27-29 greater regulation of other opiates;30,31 and opioid abusers switching to heroin for its lower cost.32 Many NIDUs transition to IDU, incurring greater risks.2,21,33,34 Drug cravings are intense urges to use drugs35,36 and they contribute to drug use37, relapse38, and transitioning from NIDU to IDU.39 Cravings are triggered by environmental factors and due to the significance of craving in drug use and relapse they will be part of the proposed criteria for DSM5.40,41

HIV, Hepatitis C (HCV), and Sexually-Transmitted Infections (STIs) continue to be associated with both IDU and NIDU.33,42-44 Hispanics are over-represented among both IDU and NIDU heroin users.21,23,45,46 Mexican American IDUs have very low rates of HIV.10,47 However, their HCV rates are very high and continue to increase, further compromising their health.10,48,49 They also have elevated rates of high-risk sex behaviors 33,50 and they are less likely to decrease these high-risk sex behaviors than they are to decrease their injection- behavior risks, especially as they age.10,51 Furthermore, HIV/HCV/STI prevention interventions can lead to fatigue52-54 so they must continue to be delivered to at-risk populations across all relevant settings. Young Texans ages 15-24 are becoming HIV infected at high rates, with Hispanics disproportionately impacted and diagnosed later: 42% of infected Texan Hispanics receive an HIV-positive and an AIDS diagnosis within the same year, compared to 32% of Anglos and 31% of Blacks.55 Thus, early detection of high-risk Hispanics is vital, making this proposal timely and critical.

Greatly needed are novel interventions that address drug cravings (DCs), take into account environmental context, and incorporate HIV/HCV prevention components. Developing these interventions and adapting them to the many diverse at-risk populations, however, can be costly and challenging. Cue exposure therapy (CET)56,57 may be a viable approach. CET is a promising intervention that can decrease DCs by repeatedly exposing an individual to a craving inducing stimulus (e.g., a shooting gallery scenario) while simultaneously preventing the conditioned behavioral response (e.g., drug use). The individual can be trained in vitro (in the lab) to use coping skills in direct response to activated cravings, then use these skills in vivo (in the natural environment). A challenge associated with CET, for both ethical and logistical reasons, is the ability to expose individuals to realistic simulated cues of the natural environment in a secure laboratory or therapeutic setting. Virtual Reality (VR) is an innovative, cutting-edge tool that can enable researchers to overcome these obstacles. VR scenarios integrate elements from the individual's various contexts-culture, neighborhood, family, networks, and individual characteristics-into the clinical or lab setting, and provide complex multi-sensory cues through an immersive human-computer interaction.58

The public health significance of this primary project is high. Drug use in general and injection drug use (IDU) in particular are serious public health concerns, as are the rates of HCV and STIs in IDUs. Interventions that decrease craving, increase coping skills, and incorporate HIV/HCV/STI prevention components can be critical tools in treating drug use disorders and their serious health consequences. In addition, it is critical to train diverse researchers who possess intimate knowledge of the populations impacted by drug use and who understand the cultural and contextual elements of those populations, to conduct this innovative research.

The specific research hypotheses and objectives are as follows:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Injection or Non-Injection heroin user, 3 or more years of heroin use, Hispanic/Latino

排除标准

  • Non heroin user, non-Hispanic/Latino, younger than 18 or older than 64, treated with any medications having a potential effect on heroin craving, mood, or heroin cessation medications in the past 30 days; use of other prescription and non-prescription drugs that may affect participation; Fear of closed spaces or inability to wear VR goggles; Visual problems that effect viewing VR materials; History of seizures or seizure disorders; History of serious self-reported health problems; and women who are pregnant

结局指标

主要结局

Self-reported reactivity to cues

时间窗: 3 hours (6 blocks of 3 minutes with time in between each block); this is done in two consecutive weeks.

Self-reported craving on a scale from 0 (none) to 100 (highest ever)

Lab-based reactivity to cues

时间窗: 3 hours (6 blocks of 3 minutes with time in between each block); this is done in two consecutive weeks. These are monitored continuously every 10th of a second.

Heart rate (ECG) assessed in beats per minute using a Bioradio Wireless Physiology (see https://glneurotech.com/bioradio/psychophysiology-equipment/).

次要结局

  • Number of times of self-reported drug use in vivo during the week between lab sessions.(Continuously during the 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis R. Torres, PhD

Associate Professor

University of Houston

研究点 (2)

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