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Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use

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ClinicalTrials.gov Identifier: NCT03648684
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Alison Looby, University of Wyoming

Tracking Information
First Submitted Date  ICMJE July 5, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date October 10, 2018
Actual Study Start Date  ICMJE September 4, 2018
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • Prescription Stimulant Expectancy Modification [ Time Frame: 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.
  • Incidence of nonmedical prescription stimulant use [ Time Frame: 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 [ Time Frame: 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.
  • Achievement Needs Modification - Academic Achievement Goals [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03648684 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • Intention to Use [ Time Frame: 7 months ]
    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.
  • Modification of Caffeine Expectancy Effects [ Time Frame: 7 months ]
    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.
  • Modification of Alcohol Expectancy Effects [ Time Frame: 7 months ]
    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).
  • Subjective Mood and Arousal [ Time Frame: 2 weeks ]
    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.
  • Subjective Drug Effects [ Time Frame: 2 weeks ]
    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.
  • Conners' Continuous Performance Test III [ Time Frame: 2 weeks ]
    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.
  • Selective Reminding Test [ Time Frame: 2 weeks ]
    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).
  • Paced Auditory Serial Addition Test [ Time Frame: 2 weeks ]
    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.
  • Stroop Test [ Time Frame: 2 weeks ]
    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).
  • Letter-Number Sequencing [ Time Frame: 2 weeks ]
    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.
  • Verbal Fluency [ Time Frame: 2 weeks ]
    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.
  • Symbol Search [ Time Frame: 2 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use
Official Title  ICMJE Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Prescription Drug Abuse (Not Dependent)
Intervention  ICMJE
  • Behavioral: Caffeine-Based Expectancy Challenge
    Intervention to alter expectancies and encourage safe drug substitution (harm reduction plus expectancy modification)
  • Behavioral: Placebo-Based Expectancy Challenge
    Intervention to alter expectancies (expectancy modification only)
Study Arms  ICMJE
  • Experimental: Caffeine-Based Expectancy Challenge
    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.
    Intervention: Behavioral: Caffeine-Based Expectancy Challenge
  • Placebo Comparator: Placebo-Based Expectancy Challenge
    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.
    Intervention: Behavioral: Placebo-Based Expectancy Challenge
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, Greek involvement, GPA < 3.5, past two-week binge drinking, past-month marijuana, any 6-month intention to engage in nonmedical prescription stimulant use, any decrements in refusal self-efficacy for prescription stimulants
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Alison Looby, PhD 3073142314 alooby@uwyo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03648684
Other Study ID Numbers  ICMJE 20180620AL02017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alison Looby, University of Wyoming
Study Sponsor  ICMJE University of Wyoming
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alison Looby, PhD University of Wyoming
PRS Account University of Wyoming
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP