Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use

Prescription Drug Abuse (Not Dependent) Clinical Trial

Official title:

Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648684
• Other study ID #: 20180620AL02017
• Status: Completed
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: November 2020
• Source: University of Wyoming
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Prescription Drug Abuse (Not Dependent)
• Substance-Related Disorders

Intervention

Behavioral:
• Caffeine-Based Expectancy Challenge
Intervention to alter expectancies and encourage safe drug substitution (harm reduction plus expectancy modification)
• Placebo-Based Expectancy Challenge
Intervention to alter expectancies (expectancy modification only)

Locations

Country	Name	City	State
United States	University of Wyoming	Laramie	Wyoming

Sponsors (1)

Lead Sponsor	Collaborator
University of Wyoming

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Intention to Use	Intention to engage in nonmedical prescription stimulant use in the following 6 months will be assessed as a proxy of incident of use, and used in analyses if incidence of use is low across all groups. This will be assessed via a 100mm Visual Analogue Scale (0-100). Higher scores indicate higher intention to engage in use.	7 months
Secondary	Modification of Caffeine Expectancy Effects	The Caffeine Expectancy Questionnaire will be used to examine whether expectancy effects for caffeine were modified for the Caffeine-Based Expectancy Challenge group specifically. This measure includes 7 factors, though only Energy/work enhancement, social/mood enhancement, and anxiety/negative physical effects will be analyzed. Items are answered along a 6 point scale (0-5), and scores for each factor are averaged; higher scores indicate stronger expectancies.	7 months
Secondary	Modification of Alcohol Expectancy Effects	The Comprehensive Effects of Alcohol Questionnaire will be used to examine whether expectancy effects for alcohol are modified over time; this is being utilized to ensure that the interventions had specific effects on prescription stimulants and caffeine, and not substance use in general. Positive and negative expectancies can be assessed with this measure, and scores are computed by averaging items loading onto each factor. Items are scored along a 4 point scale (0-3).	7 months
Secondary	Subjective Mood and Arousal	Changes in subjective mood and arousal will be assessed across laboratory visits (i.e., to examine whether expectation to receive Adderall and/or ingestion of 200mg caffeine affects subjective mood) using Visual Analogue Scales. Participants will complete scales for the following items: how well do they expect to perform, feeling good, feeling bad, feeling attentive, feeling focused, feeling high, feeling stimulated, feeling motivated, and amount of effort intended to put forth. Each item is measured along a 100mm scale (0-100), with higher scores indicating stronger subjective effects.	2 weeks
Secondary	Subjective Drug Effects	Changes in experienced drug effects will be assessed across laboratory visits (i.e., to examine whether expectation to receive Adderall and/or ingestion of 200mg caffeine affects experienced drug effects) via the Addiction Research Center Inventory. This measure includes 5 subscales: euphoria (scores range from 0-15), dysphoria (scores range from 0-14), intellectual energy and efficiency (scores range from 0-13), amphetamine effects (scores range from 0-11), and sedation (scores range from 0-15). Higher scores indicate stronger experienced drug effects in each domain.	2 weeks
Secondary	Conners' Continuous Performance Test III	The Conners' Continuous Performance Test III will be used to assess changes in attention, impulsivity, and vigilance across laboratory visits. T-scores are provided for each measure. T-scores between 45 and 69 indicate average performance, while scores outside of that range indicate performance difficulties.	2 weeks
Secondary	Selective Reminding Test	The Selective Reminding Test is a measure of learning and memory to assess whether there are differences across laboratory visits. Number of words (out of 12) recalled across 6 trials are tallied for a measure of immediate memory (range: 0-72). Additionally, the number of words recalled across consecutive trials are measured as an index of movement into long term storage (with higher scores indicating better memory; range: 0-72). Long-term memory is also assessed (range: 0-12, with higher scores indicating better memory), as is recognition memory (range: 0-12, with higher scores indicating better memory).	2 weeks
Secondary	Paced Auditory Serial Addition Test	The Paced Auditory Serial Addition Test will be used to assess differences in processing speed and divided attention across laboratory visits. This test includes 4 trials, each of which provides a total correct score out of 25. A total score is computed (0-100), with higher scores indicating better performance.	2 weeks
Secondary	Stroop Test	The Stroop Test will be used to assess differences in selective attention and processing speed across laboratory visits. This test provides reaction time scores for correct trials (smaller scores indicate better performance), as well as percentage of correct trials (out of 100%; higher scores indicate better performance).	2 weeks
Secondary	Letter-Number Sequencing	The Letter-Number Sequencing test will be used to assess differences in working memory across laboratory visits. This test provides a total score correct (range: 0-30), with higher scores indicating better performance.	2 weeks
Secondary	Verbal Fluency	The Verbal Fluency test will be used to assess verbal fluency and information retrieval across laboratory visits. A total score correct is calculated (no maximum score), with higher scores indicating better performance.	2 weeks
Secondary	Symbol Search	The Symbol Search test will be used to assess processing speed across laboratory visits. A total score correct is calculated (range: 0-60), with higher scores indicating better performance.	2 weeks