Clinical trial NCT03648684: Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use
Official title: Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prescription Drug Abuse (Not Dependent)
Keywords: Nonmedical prescription stimulant use
Expectancy challenge
College students
Lead sponsor: University of Wyoming
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prescription Stimulant Expectancy Modification
timeFrame: 7 months
measure: Incidence of nonmedical prescription stimulant use
timeFrame: 7 months
measure: Achievement Needs Modification - Self Efficacy for Learning
timeFrame: 7 months
measure: Achievement Needs Modification - Academic Achievement Goals
timeFrame: 7 months
Secondary outcomes:
measure: Intention to Use
timeFrame: 7 months
measure: Modification of Caffeine Expectancy Effects
timeFrame: 7 months
measure: Modification of Alcohol Expectancy Effects
timeFrame: 7 months
measure: Subjective Mood and Arousal
timeFrame: 2 weeks
measure: Subjective Drug Effects
timeFrame: 2 weeks
measure: Conners' Continuous Performance Test III
timeFrame: 2 weeks
measure: Selective Reminding Test
timeFrame: 2 weeks
measure: Paced Auditory Serial Addition Test
timeFrame: 2 weeks
measure: Stroop Test
timeFrame: 2 weeks
measure: Letter-Number Sequencing
timeFrame: 2 weeks
measure: Verbal Fluency
timeFrame: 2 weeks
measure: Symbol Search
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Laramie
country: United States
facility: University of Wyoming
state: Wyoming
Study officials:
affiliation: University of Wyoming
name: Alison Looby, PhD
role: PRINCIPAL_INVESTIGATOR
References: