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Prescription Drug Abuse (Not Dependent)NCT03648684

Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use

A study testing Caffeine-Based Expectancy Challenge in people with Prescription Drug Abuse (Not Dependent), run by University of Wyoming at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Prescription Drug Abuse (Not Dependent)
What is being tested?
Caffeine-Based Expectancy Challenge
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
131 participants
Where
1 siteUnited States
Study dates
4 Sep 2018to 1 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • University of Wyoming

    Laramie, Wyoming, 82071

Other trials in United States

About this study

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.

Being tested
Caffeine-Based Expectancy Challenge, Placebo-Based Expectancy Challenge
Keywords
Nonmedical prescription stimulant use, Expectancy challenge, College students
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caffeine-Based Expectancy ChallengeBehavioural

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

  • Placebo-Based Expectancy ChallengeBehavioural

    Intervention to alter expectancies (expectancy modification only)

Study groups in NCT03648684
Study groupRoleWhat they receive
Caffeine-Based Expectancy ChallengeExperimentalParticipants 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.
Receives: Behavioral: Caffeine-Based Expectancy Challenge
Placebo-Based Expectancy ChallengePlacebo comparatorParticipants 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.
Receives: Behavioral: Placebo-Based Expectancy Challenge
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 months

  2. 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.

    Measured: 7 months

  3. 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.

    Measured: 7 months

  4. 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.

    Measured: 7 months

Secondary outcomes (12)
  1. 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.

    Measured: 7 months

  2. 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.

    Measured: 7 months

  3. 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).

    Measured: 7 months

  4. 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.

    Measured: 2 weeks

  5. 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.

    Measured: 2 weeks

  6. 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.

    Measured: 2 weeks

  7. 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).

    Measured: 2 weeks

  8. 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.

    Measured: 2 weeks

  9. 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).

    Measured: 2 weeks

  10. 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.

    Measured: 2 weeks

  11. 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.

    Measured: 2 weeks

  12. 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.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2018
  2. Study start4 Sep 2018
  3. Primary completion1 Oct 2020
  4. Study completion1 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03648684
Sponsor's protocol ID
20180620AL02017
Status last verified
Nov 2020
First submitted
5 Jul 2018
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37740001

Questions about this trial

What is this clinical trial studying?

A study testing Caffeine-Based Expectancy Challenge in people with Prescription Drug Abuse (Not Dependent), run by University of Wyoming at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prescription Stimulant Expectancy Modification (time frame: 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03648684, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

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