Effects of Commonly Used Medications on Mood and Choice

Study Overview
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Brief Summary
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This non-treatment study will examine how commonly used prescription or over-the-counter medications may influence mood and medication preference.

Detailed Description
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Volunteers (aim is 36 completers) will participate in a double-blind study conducted over a period of about 14-17 weeks including sessions for screening, food and beverage diary review (Phase 1), drug exposure and choice sessions (Phase 2), and no-choice exposure sessions (Phase 3). During Phases 2 and 3, participants will orally ingest capsules containing varying doses of commonly prescribed over-the-counter medications and/or placebo. During screening, participants will be asked questions about participants' general characteristics including demographic information, mood, and personality. Participants will also be examined to determine medical eligibility. Eligible participants will proceed to Phase 1 in which participants will be asked to eliminate certain foods and beverages from participants diet, record participants daily food and beverage consumption and attend the laboratory approximately three times per week to discuss participants' food diaries. During Phases 2 and 3 food and beverage restrictions will remain in place and participants will report to the laboratory 2-5 times weekly in order to ingest study capsules and fill out questionnaires (e.g., about participants' current mood). After leaving the laboratory, participants will be asked to fill out surveys remotely in order to describe the effects of that session's capsules on mood and preference.

Official Title
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Effects of Commonly Used Medications on Mood and Choice

Conditions
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Healthy

Intervention / Treatment
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* Drug: Effects of commonly used medications on mood and medication preference


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Fluent in written and spoken English and is capable of understanding and complying with the protocol Medically healthy Non-smoker Appropriate dietary/over-the-counter/prescription/illicit drug use history Body Mass Index between 18.5 and 35 Appropriate use of birth control in females e.g., barrier methods, hormonal contraceptives, Intra Uterine Devices (IUDs) Exclusion Criteria: Known hypersensitivity to administered drugs Current neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary or metabolic disease for which administration of the study drugs would be contraindicated Current psychiatric or substance use condition that would interfere with study participation Diastolic blood pressure >90 mmHg or a systolic pressure of >140 mmHg Use of medications that would interfere with study participation Past prescriptions that may affect study participation Unwilling or unable to comply with the protocol Any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage the subjects according to the protocol Females: Pregnancy, breastfeeding, or plans to become pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are not assigned to different groups/arms [Note: we indicated 2 arms below because the form does not allow masking in a single arm study - this study involves administration of drug conditions in different dose sequence orders]. All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be different across participants. Participants will be randomly assigned to one of several different dose sequences.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Within-Subjects Dose Conditions<br>Participants are not assigned to different groups/arms. All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be different across participants. Thus, comparisons of the drug conditions on mood and choice will be compared within-subjects (e.g., between drug and placebo) and not between arms. | Drug: Effects of commonly used medications on mood and medication preference<br>* Capsules will contain a commonly prescribed or over-the-counter medication, or placebo. A placebo is an inactive substance that looks like the study drug, but contains no active drug. The capsules given in this study may include sedatives, muscle relaxants, or anti-anxiety medications, stimulant drugs/weight loss medications, and antihistamines. More drugs are listed than will be administered to increase the degree to which volunteers are blind to the drugs being studied. Participants will not be informed of the specific drugs they will receive during or after the study. Participants will not receive any drug that is not named as a possible study drug in the written informed consent form. All the study drugs to be administered are legally marketed in the United States.<br>|
| Experimental: Additional Within-Subjects Dose Conditions<br>As described previously, all participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be different across participants. Thus, comparisons of the drug conditions on mood and choice will be compared within-subjects (e.g., between drug and placebo) and not between arms. We have created a second arm in the description of the trial on ClinicalTrials.gov to designate masking - this study involves administration of drug conditions in different dose sequence orders to which participants are randomly assigned. | Drug: Effects of commonly used medications on mood and medication preference<br>* Capsules will contain a commonly prescribed or over-the-counter medication, or placebo. A placebo is an inactive substance that looks like the study drug, but contains no active drug. The capsules given in this study may include sedatives, muscle relaxants, or anti-anxiety medications, stimulant drugs/weight loss medications, and antihistamines. More drugs are listed than will be administered to increase the degree to which volunteers are blind to the drugs being studied. Participants will not be informed of the specific drugs they will receive during or after the study. Participants will not receive any drug that is not named as a possible study drug in the written informed consent form. All the study drugs to be administered are legally marketed in the United States.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant subjective ratings of drug liking (peak change) | Primary outcome will be peak change in participant ratings of drug liking relative to pre-drug ratings within 4 hours post-administration. Participants rate drug liking on a scale from -4 (dislike very much) to 4 (like very much) where 0 = Neutral or No Effect. This is not a treatment study, and higher or lower ratings of drug liking do not represent better or worse outcomes. | up to 4 hours after capsule ingestion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant subjective ratings of drug value | Secondary outcome will be subject rating of monetary drug value as assessed post-administration. Participants will rate the subjective value of the drug on a scale from -$30 (i.e., they would prefer to lose $30 rather than take the drug) to $30 (i.e., they would prefer to take today's drug instead of receiving $30). This is not a treatment study, and higher or lower ratings of drug value do not represent better or worse outcomes. | Completed by the participant up to 4 hours after capsule ingestion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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over-the-counter, prescription medication, subjective effects