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Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use

U

University of Wyoming

Status

Completed

Conditions

Prescription Drug Abuse (Not Dependent)

Treatments

Behavioral: Caffeine-Based Expectancy Challenge
Behavioral: Placebo-Based Expectancy Challenge

Study type

Interventional

Funder types

Other

Identifiers

NCT03648684
20180620AL02017

Details and patient eligibility

About

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.

Enrollment

131 patients

Sex

All

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

131 participants in 3 patient groups, including a placebo group

Caffeine-Based Expectancy Challenge
Experimental group
Description:
Participants will ingest caffeine under the guise of Adderall prior to completing tasks. They will engage in an expectancy challenge intervention designed to both challenge expectancies for prescription stimulants and promote safe caffeine use for cognitive/mood enhancement.
Treatment:
Behavioral: Caffeine-Based Expectancy Challenge
Placebo-Based Expectancy Challenge
Placebo Comparator group
Description:
Participants will ingest placebo under the guise of Adderall prior to completing tasks. They will engage in an expectancy challenge intervention designed to challenge expectancies for prescription stimulants.
Treatment:
Behavioral: Placebo-Based Expectancy Challenge
Control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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