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临床试验/NCT06395389
NCT06395389招募中不适用

Development of a Novel Cannabis Brief Intervention for Frequently-Using Emerging Adults: Pilot Randomized Trial

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年10月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
62
试验地点
1
主要终点
Timeline Followback (TLFB)

研究概览

简要总结

The purpose of this study is to compare two brief interventions targeting potentially problematic cannabis use in emerging adults (ages 18-25). Brief interventions are two 40-50 minute sessions separated by 1 week. Eligible emerging adults will complete a detailed cannabis assessment (biological and self-report), followed by one of the two brief interventions, and four follow-up assessments: one immediately after the second session and at 1-, 3-, and 6-months post-intervention. Assignment to the brief intervention is random. Salivary samples will be collected at baseline, post-intervention, and all follow-ups, for a total of 5 samples, to be tested for tetrahydrocannabinol (THC) and cannabidiol (CBD).

详细描述

Cannabis is the most widely used federally illicit substance among emerging adults (age 18-25) in the U.S., and frequent cannabis use is associated with myriad long-term health, social, and academic/occupational consequences. Despite this, rates of perceived risk of daily/regular cannabis use have steadily declined over the past two decades, and this is associated with increased frequency of use, a risk for for Cannabis Use Disorder (CUD). Brief interventions (BIs) are among the most frequently used approaches for addressing problematic or potentially problematic substance use in non-treatment-seeking adolescents and young adults. Although several cannabis brief interventions have been developed and tested to date, meta-analyses indicate that the efficacy of these interventions for emerging adults is mixed and the quality of studies is low, suggesting that novel approaches and rigorous methodology are necessary to improve efficacy. The current study will evaluate the feasibility, acceptability, and preliminary efficacy of a novel cannabis BI for emerging adults who frequently use cannabis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Self-Report report cannabis use on at least 20 days of the past 30 days
  • Submit a positive urine cannabinoid test

排除标准

  • Currently engaged in substance use treatment for any type of substance use or currently treatment seeking
  • History of substance use treatment for any type of substance
  • Severe alcohol use disorder or indication of any substance use disorder requiring a higher level of care (AUDIT score ≥14 or DUDIT score ≥2 for women, ≥6 for men)
  • Significant or acutely unstable medical or psychiatric problems (i.e., psychosis, mania) that would contraindicate research procedures, interfere with safety, compromise data integrity, or preclude consistent study participation (Screening psychosis score =7)
  • Significant risk of suicide or homicide
  • Currently pregnant or breastfeeding

研究组 & 干预措施

Health Education (HealthEdu)

Active Comparator

Brief intervention providing recommendations/advice for good sleep hygiene, nutrition and physical activity, stress, and relationships.

干预措施: Health Education (HealthEdu) (Behavioral)

Bloom

Experimental

Brief intervention providing personalized discussion of values/goals, reasons for cannabis use, and strategies to help live in line with values and achieve goals.

干预措施: Bloom (Behavioral)

结局指标

主要结局

Timeline Followback (TLFB)

时间窗: Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up

The TLFB is a calendar based assessment that is able to capture the frequency and quantity of substance use and other measurable behaviors. Responders identify anchor dates to facilitate recall of days in which substances were used.

次要结局

  • Marijuana Assessment of Problems Inventory (MAPI)(Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)
  • Oral Fluid Biospecimen Assay(Baseline, 2-week follow-up, 1-month follow-up, 3-month follow-up, 6-month follow-up)
  • Mini International Neuropsychiatric Interview (MINI) Cannabis Use Disorder Module(Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)

研究者

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

Kathryn Gex

Assistant Professor-Faculty

Medical University of South Carolina

研究点 (1)

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