跳至主要内容
临床试验/NCT03648684
NCT03648684已完成不适用

Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use

University of Wyoming2 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2018年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
131
试验地点
2
主要终点
Incidence of nonmedical prescription stimulant use

研究概览

简要总结

Nonmedical prescription stimulant use (NPS) is commonly reported among college students for cognitive enhancement purposes, though it is associated with numerous negative psychological and physical consequences. Despite increasingly high prevalence rates and widespread acknowledgement of the need for efficacious interventions, little is known regarding how to prevent or treat this behavior. An intervention that targets cognitive enhancement motives and expectancy effects related to NPS may be particularly effective in light of recent research purporting limited evidence for meaningful NPS-related cognitive improvements among individuals without legitimate attention deficits. The primary objective of this proposal is to examine the efficacy of an intervention that successfully prevents NPS among college students by modifying expectations for NPS-related effects, while at the same time providing alternative means of enhancing cognition and arousal. Participants will be 126 stimulant-naïve college students who report a combination of risk factors for NPS. They will be randomized to one of three treatment conditions: a placebo-based expectancy challenge intervention that solely aims to modify expectancies related to NPS, a caffeine-based expectancy challenge intervention that includes expectancy modification combined with a safer alternative for cognitive enhancement, or a control group. Multilevel mixed modeling and survival analyses will be used to 1) examine changes in NPS-related expectancy effects across a 6-month follow-up period, and 2) assess incidence of NPS over the follow-up period, respectively, across the three groups. It is hypothesized that both expectancy challenge interventions will successfully modify expectancies compared to the control group and that they will be maintained over the follow-up period. It is also expected that the caffeine-based intervention will most successfully prevent NPS through a combination of expectancy modification and encouraging safe use of caffeine rather than prescription stimulants to achieve desired outcomes. Mediational analyses will also be employed to assess whether changes in expectancy effects via the interventions are responsible for differences in initiation rates between groups. The results of this project will facilitate the development of larger-scale prevention efforts to target the high rate of NPS on college campuses.

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 (Participant)

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

  • Native English speakers
  • Current undergraduate enrollment
  • Prescription stimulant naive
  • At-risk for nonmedical prescription stimulant use, defined by endorsement of 2+ risk factors: male sex OR white race, Greek involvement, GPA < 3.5, past two-week binge drinking, past-month marijuana
  • Willingness to ingest Adderall in the laboratory
  • Past-month caffeine use

排除标准

  • Lifetime history of use of any prescription stimulant
  • Current psychiatric diagnosis
  • Current psychiatric medication use
  • Smoking > 5 cigarettes daily or daily use of any other nicotine product
  • History of cardiac problems, diabetes, or regular hypoglycemia
  • Current pregnancy or breastfeeding
  • History of adverse reactions to caffeine

结局指标

主要结局

Incidence of nonmedical prescription stimulant use

时间窗: 7 months

Whether or not participants initiate nonmedical prescription stimulant use, and the approximate date, will be assessed over the follow-up period.

Achievement Needs Modification - Self Efficacy for Learning

时间窗: 7 months

Achievement needs are being assessed via the Self Efficacy for Learning Form. Items on the Self Efficacy for Learning Form are each scored from 0 - 100 with regard to percent confidence that each behavior can be carried out. Scores across items will be averaged for a total score ranging from 0 to 100, with lower scores indicating poorer self-efficacy and consequently higher achievement needs.

Prescription Stimulant Expectancy Modification

时间窗: 7 months

This will be assessed via changes on the Prescription Stimulant Expectancy Questionnaire-II. This scale includes 4 subscales, each of which will be assessed: cognitive enhancement, social enhancement, guilt and dependence, and anxiety and arousal. Each item is assessed on a 5-point scale, and scores for each subscale are calculated by averaging across relevant items (i.e., scores on each factor can range from 0-4); higher scores indicate stronger expectancies in that domain.

Achievement Needs Modification - Academic Achievement Goals

时间窗: 7 months

Achievement needs are also being assessed via the Academic Achievement Goal Questionnaire. A total score will be used for this measure. Each item is answered on a 7 point scale; thus, scores can range from 0 to 72, with higher scores indicating strong achievement goals/needs.

次要结局

  • Intention to Use(7 months)
  • Modification of Caffeine Expectancy Effects(7 months)
  • Modification of Alcohol Expectancy Effects(7 months)
  • Subjective Mood and Arousal(2 weeks)
  • Subjective Drug Effects(2 weeks)
  • Conners' Continuous Performance Test III(2 weeks)
  • Selective Reminding Test(2 weeks)
  • Paced Auditory Serial Addition Test(2 weeks)
  • Stroop Test(2 weeks)
  • Letter-Number Sequencing(2 weeks)
  • Verbal Fluency(2 weeks)
  • Symbol Search(2 weeks)

研究者

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

Alison Looby

Assistant Professor

University of Wyoming

研究点 (2)

Loading locations...

相似试验