Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use

NCT03648684 | Completed

• 1 other identifier: 20180620AL02017
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Prescription Drug Abuse (Not Dependent)

Keywords

Nonmedical prescription stimulant use; Expectancy challenge; College students

Outcome Measures

Primary Outcomes (4)

• Prescription Stimulant Expectancy Modification

  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.

  7 months

• Incidence of nonmedical prescription stimulant use

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

  7 months

• Achievement Needs Modification - Self Efficacy for Learning

  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.

  7 months

• Achievement Needs Modification - Academic Achievement Goals

  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.

  7 months

Secondary Outcomes (12)

• 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

Study Arms (3)

Caffeine-Based Expectancy Challenge

EXPERIMENTAL

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.

Behavioral: Caffeine-Based Expectancy Challenge

Placebo-Based Expectancy Challenge

PLACEBO COMPARATOR

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.

Behavioral: Placebo-Based Expectancy Challenge

Control

NO INTERVENTION

Interventions

Caffeine-Based Expectancy Challenge BEHAVIORAL

Intervention to alter expectancies and encourage safe drug substitution (harm reduction plus expectancy modification)

Caffeine-Based Expectancy Challenge

Placebo-Based Expectancy Challenge BEHAVIORAL

Intervention to alter expectancies (expectancy modification only)

Placebo-Based Expectancy Challenge

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wyoming: lead

Study Sites (1)

University of Wyoming

Laramie, Wyoming, 82071, United States

Location

Related Publications (1)

• Looby A, Piccorelli AV, Zimmerman L, Falco C, Livingston NR, Akin C, Benton S, Juliano LM. Expectancy for Adderall influences subjective mood and drug effects regardless of concurrent caffeine ingestion: A randomized controlled trial. Psychopharmacology (Berl). 2024 Jan;241(1):109-118. doi: 10.1007/s00213-023-06467-8. Epub 2023 Sep 23.

  PMID: 37740001 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Alison Looby, PhD

  University of Wyoming

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: August 27, 2018
• Study Start: September 4, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

US (1)