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
|Condition or disease||Intervention/treatment||Phase|
|Prescription Drug Abuse (Not Dependent)||Behavioral: Caffeine-Based Expectancy Challenge Behavioral: Placebo-Based Expectancy Challenge||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Examining Expectancy Challenges to Prevent Nonmedical Prescription Stimulant Use|
|Actual Study Start Date :||September 4, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||August 2020|
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.
Behavioral: Caffeine-Based Expectancy Challenge
Intervention to alter expectancies and encourage safe drug substitution (harm reduction plus expectancy modification)
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.
Behavioral: Placebo-Based Expectancy Challenge
Intervention to alter expectancies (expectancy modification only)
|No Intervention: Control|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648684
|Contact: Alison Looby, PhDfirstname.lastname@example.org|
|United States, Wyoming|
|University of Wyoming||Recruiting|
|Laramie, Wyoming, United States, 82071|
|Contact: Alison Looby, PhD|
|Principal Investigator:||Alison Looby, PhD||University of Wyoming|