Bright Light Therapy During Inpatient Cocaine Detoxification
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Percentage of cocaine-free days (PCFD) over the one-month follow-up
研究概览
简要总结
Cocaine is a major psychostimulant used to induce a state of euphoria, improved self-confidence and resistance to fatigue, with suppression of sleep. The progressive use of cocaine leads to a potentially severe addictive process, with sometimes dramatic social repercussions, a major disruption of major physiological functions, such as sleep or nutrition, and risks of psychiatric, neurological or cardiovascular complications.
Today, cocaine addiction is considered to be a growing societal problem, due to the fact that the use of this drug is becoming commonplace. There is no validated consensus or protocol for the management of cocaine addiction and no validated pharmacological treatment. The main therapeutic strategy for cocaine addiction is to organize a supervised cessation of use (withdrawal), followed by assistance in maintaining cessation. Withdrawal is a sensitive period that frequently takes place in a hospital setting, as withdrawal symptoms can occur, with major disruption of circadian rhythms, night-time awakenings, daytime sleepiness, high irritability, and sometimes depression.
Reducing the desynchronization of nychthemeral cycles during cocaine withdrawal could be a simple strategy to improve the addictive prognosis and comfort of patients. Light therapy is a medical device consisting of the emission of white light enriched with blue light by a lamp or glasses with an intensity sufficient to stimulate the melanopsin cells of the retina and mimic daylight. Overall, light therapy improves sleep quality, mood, cognitive abilities, and decreases fatigue through direct activation of non-visual brain structures. Given the links between cocaine withdrawal and altered sleep or rhythms, there is some evidence to suggest that light therapy used during cocaine withdrawal may improve the prognosis of patients with cocaine addiction.
详细描述
CokeLux is a multicenter, randomized, sham-controlled, double blind clinical trial, which corresponds to a clinical investigation with a category 4.3 medical device.
After an initial pre-hospitalization assessment, which will include clinical and sociodemographic parameters, participants will undergo a hospital-based cocaine detoxification which will last 10 to 17 days. After discharge, the intervention procedure will be stopped, but the collection of clinical and paraclinical data will be continued during the month following hospital discharge
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
- Double (Participant, Outcomes Assessor)
盲法说明
Only the biostatistician in charge of producing the randomization list, and the pharmacy of the coordinating centers that will manage the conditioning, labeling, and shipping of the medical devices used by the different centers, will possess the information about which group a given participant belongs to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age or older
- •DSM-5 criteria for cocaine use disorder
- •Positive urine screen for cocaine
- •Hospitalization for supervised cocaine detoxification planned within the four upcoming weeks
- •The patients must be insured or beneficiary of a health insurance plan
- •Signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the trial
排除标准
- •Non-stabilized opioid use disorder or other psychostimulant use disorder (e.g., amphetamine, met-amphetamine, cathinones, methylphenidate…)
- •Non-stabilized psychiatric disorder or somatic disease, which is considered incompatible with inclusion by the investigator
- •Current treatment with methylphenidate, modafinil, solriamfetol, melatonin pitolisant, naltrexone, or bupropion.
- •Contraindication to light therapy: retinopathy, pigmentary retinitis, diabetic retinopathy, macular degeneration, glaucoma, recent (i.e., less than three month) eye surgery. (If there is any doubt about an ophthalmological contraindication, a specialist opinion will be requested)
- •Tutorship
- •Pregnant or breastfeeding women: the performance of a pregnancy test before inclusion for women of childbearing age
- •Persons deprived of their liberty by a judicial or administrative decision
- •Persons participating in other research with an exclusion period still in progress at pre-inclusion
研究组 & 干预措施
Cyan light therapy
Cyan light therapy involves the use of a medical device (usually a light-emitting diode, or LED) that emits cyan light, which is thought to stimulate the melanopsin-containing cells in the retina, in the same way as daylight.
干预措施: Medical light therapy device (Device)
Sham light therapy
The comparison procedure will use the same model of medical device (DAYVIA SUNACTIV-2®) with CE marking, but with an attenuated form of light, i.e., <50 lux without blue light (600nm) that is unable to activate melanopsin cells (see for example Chojnacka et al., 2016) and therefore devoid of psychotropic or hypnotic effect.
干预措施: Medical light therapy device sham (Device)
结局指标
主要结局
Percentage of cocaine-free days (PCFD) over the one-month follow-up
时间窗: One month
Both cocaine abstinence and reduced frequency of cocaine use, measured as fewer days of use per week, were associated with significant clinical benefits across psychological, family, employment, and legal domains
Time taken before the first relapse
时间窗: One month
Use of cocaine, of any kind
Proportion of continuous cocaine abstinent patients during the one-month follow-up period
时间窗: One month
Abstinence rate
次要结局
未报告次要终点