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Examining Clinical Research Participation for Substance Abuse Disorder Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05881369
Recruitment Status : Not yet recruiting
First Posted : May 31, 2023
Last Update Posted : May 31, 2023
Sponsor:
Information provided by (Responsible Party):
Power Life Sciences Inc.

Study Description
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Brief Summary:

Clinical study participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through.

The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future substance abuse disorder patients during clinical trials.


Condition or disease
Substance Abuse Disorder

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Exploring the Clinical Trial Journey of Patients in Substance Abuse Disorder Clinical Trials
Estimated Study Start Date : June 2024
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2026
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Rate of patients who decide to enroll in a substance abuse disorder clinical study. [ Time Frame: 3 months ]
  2. Number of substance abuse disorder patients who remain in clinical trial until completion. [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Substance abuse disorder patients who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.
Criteria

Inclusion Criteria:

  • Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
  • Participant has a diagnosis of substance abuse disorder.
  • Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

  • Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
  • Pregnant or lactating woman
  • Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results
Contacts and Locations
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Information from the National Library of Medicine

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): NCT05881369


Contacts
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Contact: Michael B Gill 415-900-4227 bask@withpower.com

Locations
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United States, California
Power Life Sciences
San Francisco, California, United States, 94107
Contact: Michael B Gill    415-900-4227    https://www.withpower.com/contact-us@withpower.com   
Sponsors and Collaborators
Power Life Sciences Inc.
Investigators
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Study Director: Michael B Gill Power Life Sciences Inc.
  Study Documents (Full-Text)

Documents provided by Power Life Sciences Inc.:
Informed Consent Form  [PDF] May 19, 2023

More Information
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Publications:

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Responsible Party: Power Life Sciences Inc.
ClinicalTrials.gov Identifier: NCT05881369    
Other Study ID Numbers: 91257336
First Posted: May 31, 2023    Key Record Dates
Last Update Posted: May 31, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Power Life Sciences Inc.:
substance abuse disorder
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders