Neuroimaging of Instrumental Learning Networks in Adolescent Cannabis Use Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cannabis use frequency
研究概览
简要总结
This study is testing whether brain activity related to learning can help predict how well teens respond to a treatment program designed to reduce cannabis use. Teens ages 14-17 will complete a brain scan and then take part in 10 weekly virtual sessions where they report cannabis use and complete drug tests at home. Participants can earn prizes for staying cannabis-free.
详细描述
This is a 13-week clinical trial to examine whether success during contingency management treatment for cannabis use is associated with baseline functioning of instrumental learning neuro-circuitries. The investigators propose to recruit N=80 youths ages 14-17 with varying levels of cannabis use. Following phone prescreening, participants will undergo informed consent/assent and eligibility assessment with an in-person visit. Participants who are eligible will undergo a functional magnetic resonance imaging (fMRI) scan where participants will perform an instrumental learning task during a second in-person visit. At this visit, participants and participants' guardians or most recent caregiver will be provided with ten urine drug screens. A tutorial will be provided by study staff on how to administer and read urine drug screens. After the fMRI scan, participants will undergo ten weekly virtual contingency management sessions administered via HIPAA-compliant telehealth software (e.g., Microsoft Teams). At each contingency management (CM) session, participants will be asked to provide a urine sample, and participants' guardians will be asked to administer the urine drug screen based on this sample. At each contingency management session, the timeline followback will be used to assess which days since the last session participants used cannabis at all. Finally, at each contingency management session, participants will answer brief questionnaires regarding participants' current cannabis cravings and cannabis withdrawal symptoms. For the first two sessions, participants will be able to spin a virtual wheel to win prizes (either positive affirmations or amazon gift cards in varying amounts from $5-$100) for producing a urine drug screen and answering the questions. For sessions 3-10, participants will spin the virtual wheel to win prizes after producing a urine drug screen that is negative for cannabinoids and reporting that they have not used cannabis since the last session. After the ten weekly contingency management sessions, participants will return for an in-person visit where participants will answer questions regarding their cannabis use disorder symptoms during the contingency management treatment and readiness to change. The investigators' specific aims are to identify associations between baseline Cannabis Use Disorder (CUD) symptom levels and neural activity during instrumental learning in cannabis-using adolescents (Aim 1) and Identify associations between neural activity during instrumental learning and reductions in cannabis use frequency during contingency management (Aim 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •14-17 year old youth
- •Guardian 18 years or older
- •Youth is MRI-eligible: No metal implants, prosthetics, orthodontic devices, transdermal medication patches, piercings and/or hair or eyelash extensions that cannot easily be removed, metallic ink tattoos on the neck or face, or claustrophobia, and are not pregnant
- •Youth must endorse having used cannabis at least once per week over the past month OR youth must have been diagnosed with cannabis use disorder within the past three months
排除标准
- •Youth has a history of Fetal Alcohol Spectrum Disorder, intellectual disorders, pervasive development disorder or autism spectrum disorder, psychotic disorders, history of neurological problems (epilepsy, traumatic brain injury, brain tumor, cerebrovascular disease) by parent/guardian report
- •Youth or caretaker who is monolingual non-English speaker
- •Youth who is currently experiencing active psychosis symptoms or suicidal/homicidal ideation or who has been hospitalized within the past 6 months for psychosis or suicidality/homicidality
- •Youth who is currently undergoing contingency management treatment for cannabis use disorder
研究组 & 干预措施
Contingency Management and Elastic Net Regression
All participants will receive Contingency Management treatment for Cannabis Use.
An elastic net regression model will be applied to the neuroimaging data for all participants to estimate scores on the CUDIT.
干预措施: Elastic Net Regression (Device)
Contingency Management and Elastic Net Regression
All participants will receive Contingency Management treatment for Cannabis Use.
An elastic net regression model will be applied to the neuroimaging data for all participants to estimate scores on the CUDIT.
干预措施: Contingency Management (Behavioral)
结局指标
主要结局
Cannabis use frequency
时间窗: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)
The investigators will measure cannabis use frequency via percent of days where cannabis was used over the past 30 days via the Timeline Followback Scale (Sobell and Sobell, 1992)
Cannabis use frequency
时间窗: Past 30 days
The investigators will measure cannabis use frequency via percent of days where cannabis was used over the past 30 days via the Timeline Followback Scale (Sobell and Sobell, 1992)
Cannabis Use Disorder Identification Test (CUDIT) Score
时间窗: Baseline
The CUDIT (Adamson et al., 2010) is a measure of cannabis use disorder symptom level. This scale is an 8-item scale that asks about cannabis use disorder symptoms over the past year and is scored on a scale of 0 (no cannabis use in the past year) to 32 (daily cannabis use, physical and psychological dependence symptoms, severe cannabis misuse). The CUDIT will be measured once at the baseline screening visit.
次要结局
- Total quantity of cannabis use(Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit))
- Cannabis withdrawal(Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit))
- Cannabis expectancy(Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit))
- Proportion of negative cannabis urine drug screen(Screening, Baseline, once weekly at each CM visit, and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit))
- Total quantity of cannabis use(Past 30 days)
- Cannabis withdrawal(12 weeks)
- Cannabis expectancy(12 weeks)
- Proportion of negative cannabis urine drug screen(12 weeks)
研究者
Joseph Aloi
Assistant Professor
Indiana University
