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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Prescription Drug Abuse (Not Dependent)
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Placebo-Based Expectancy Challenge |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted27 Aug 2018
- Study start4 Sep 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prescription Drug Abuse (Not Dependent)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Wyoming
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Looby, University of Wyoming
- Investigators
- Alison Looby, PhD, Principal investigator, University of Wyoming
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use
- ClinicalTrials.gov ID
- NCT03648684
- Acronym / sponsor ID
- 20180620AL02017
- Conditions
- Prescription Drug Abuse (Not Dependent)
- Keywords
- Nonmedical prescription stimulant use, Expectancy challenge, College students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of WyomingUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caffeine-Based Expectancy Challenge | Experimental | Behavioral: Caffeine-Based Expectancy ChallengeParticipants 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. |
| Placebo-Based Expectancy Challenge | Placebo comparator | Behavioral: Placebo-Based Expectancy ChallengeParticipants 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. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine-Based Expectancy ChallengeIntervention to alter expectancies and encourage safe drug substitution (harm reduction plus expectancy modification) | Behavioural | Caffeine-Based Expectancy Challenge |
| Placebo-Based Expectancy ChallengeIntervention to alter expectancies (expectancy modification only) | Behavioural | Placebo-Based Expectancy Challenge |
Primary outcome
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.
12 secondary outcomes
Intention to Use
Time frame: 7 months
Modification of Caffeine Expectancy Effects
Time frame: 7 months
Modification of Alcohol Expectancy Effects
Time frame: 7 months
Subjective Mood and Arousal
Time frame: 2 weeks
Subjective Drug Effects
Time frame: 2 weeks
Conners' Continuous Performance Test III
Time frame: 2 weeks
Selective Reminding Test
Time frame: 2 weeks
Paced Auditory Serial Addition Test
Time frame: 2 weeks
Stroop Test
Time frame: 2 weeks
Letter-Number Sequencing
Time frame: 2 weeks
Verbal Fluency
Time frame: 2 weeks
Symbol Search
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 37740001Looby 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Looby, PhD principal investigator
University of Wyoming
1 site in 1 country: see every site and its status.
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.