Drug Effects on Mood and Pain in Healthy Subjects

Overseen By Justin Strickland, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Johns Hopkins University

Must not be taking: Alcohol, Benzodiazepines, Illicit drugs, others

Disqualifiers: Alcohol dependence, Hepatic disease, Depression, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 7 sessions

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different drugs and combinations affect mood, pain, and performance. The aim is to understand the impact of these medications on healthy individuals. Participants will attend various sessions with different drug doses in a randomized order. Ideal candidates for this trial do not have issues with alcohol or substance use and are free from any major physical or mental illnesses. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive a new treatment.

Will I have to stop taking my current medications?

The trial requires that you do not take medications known to interact with the study drugs. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that trials often test drugs like those in this study at very low doses. For instance, one study tested a small amount of LSD (13 micrograms) to observe its effects on mood and behavior. Participants usually tolerate these low doses well. Although specific side effects can vary by drug, trials are designed to prioritize safety.

At this early stage of clinical research, the primary focus is on safety. Researchers closely monitor participants to quickly identify and address any unwanted effects. Early trials emphasize safety, ensuring any new treatment undergoes thorough evaluation before advancing to later stages. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it aims to explore how a new drug affects mood and pain in healthy individuals. Unlike existing treatments that typically target pain or mood disorders separately and often take weeks to show results, this investigation could uncover a drug that addresses both conditions simultaneously and potentially more quickly. By using a Latin-Square randomized order, researchers are systematically varying the doses, which may help in fine-tuning the effectiveness and safety of the treatment. This innovative approach could lead to groundbreaking insights into more efficient ways to manage mood and pain, offering hope for more effective future treatments.

What evidence suggests that this trial's treatments could be effective for mood and pain?

Research shows that some drugs can affect mood and pain. For example, one study found that a small dose of LSD changed mood and behavior. Another study on a drug called BPL-003 demonstrated lasting antidepressant effects. These findings suggest that altering brain chemistry can influence mood and pain perception. Although specific data for the blinded study medication in this trial is unavailable, the mechanisms of these drugs show promise for managing mood and pain. ^{3 4 6 7 8}

Who Is on the Research Team?

Justin Stricklahd, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in participating in research on how different drugs affect mood, pain, and performance. Specific eligibility criteria are not provided here.

Inclusion Criteria

Vital signs in normal range as reviewed by study medical team

Person is willing and able to provide informed consent

I am between 18 and 55 years old.

Exclusion Criteria

Seeking treatment for alcohol or substance use

Evidence of physical dependence on alcohol or benzodiazepines based on tolerance and withdrawal upon cessation of use of alcohol or benzodiazepines reported in the Mini-International Neuropsychiatric Interview (MINI) as well as clinical interviews by medical staff during H&P

Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Treatment

Participants complete 7 study test sessions receiving a study drug that may contain blinded drugs or drug combinations

7 sessions

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Blinded Study Medication

Trial Overview The study is testing the effects of various blinded medications under five different conditions against a placebo to see their impact on participants' mood, pain perception, and cognitive or physical performance.

How Is the Trial Designed?

Group I: Experimental Session 6 Experimental Treatment 1 Intervention

This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

Group II: Experimental Session 5 Experimental Treatment 1 Intervention

This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

Group III: Experimental Session 4 Experimental Treatment 1 Intervention

This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

Group IV: Experimental Session 3 Experimental Treatment 1 Intervention

This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

Group V: Experimental Session 2 Experimental Treatment 1 Intervention

This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

Group VI: Experimental Session 1 Experimental Treatment 1 Intervention

This is the single arm that will go through all within-subject dose conditions in a Latin-Square randomized order.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2945282/

Can keeping clinical trial participants blind to their study ... Blinding subjects past their study involvement may impair their capacity to make accurate attributions for negative experiences. We should be concerned, then, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07061886

Drug Effects on Mood and Behavior - Expectancy This study will examine the effects of a single low dose of the 5HT2A agonist LSD (Lysergic Acid Diethylamide) (13 µg) or placebo in individuals who are or ...

3. psychiatrictimes.com psychiatrictimes.com/view/bpl-003-positive-phase-2b-open-label-extension-study-data

BPL-003: Positive Phase 2b Open-Label Extension Study ... AtaiBeckley reveals promising phase 2b open-label extension study results for BPL-003, showing sustained antidepressant effects in patients ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022395618310069

Impact of pharmacogenomics on clinical outcomes in major ... Patients taking incongruent medications prior to baseline who switched to congruent medications by week 8 experienced greater symptom improvement (33.5% versus ...

5. academic.oup.com academic.oup.com/ije/article/36/3/654/653829

Blinded trials taken to the test: an analysis of randomized ... A meta-analysis of studies of bias found that trials described as 'double blind' in trial reports found 14% lower treatment effects, on average, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9257339/

Assessment of blinding in randomized controlled trials ... In double-blind trials of antidepressants, blinding may still be broken due to apparent side effects of antidepressants. Detailed descriptions ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178121005928

A systematic review and meta-analysis of the success ... Double-blind randomized placebo-controlled trials (RCTs) are considered the gold standard for identifying safe and efficacious treatments to manage depression.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5549444/

Maintenance of Blinding in Clinical Trials and the ... The design of analgesic clinical trials invariably involves a comparison between placebo and active study medication.