Examining Clinical Research Participation for Substance Abuse Disorder Patient

NCT05881369 | Not Yet Recruiting

• 1 other identifier: 91257336
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Abuse Disorder

Keywords

substance abuse disorder

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a substance abuse disorder clinical study.

  3 months

• Number of substance abuse disorder patients who remain in clinical trial until completion.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• Kock P, Froelich K, Walter M, Lang U, Dursteler KM. A systematic literature review of clinical trials and therapeutic applications of ibogaine. J Subst Abuse Treat. 2022 Jul;138:108717. doi: 10.1016/j.jsat.2021.108717. Epub 2021 Dec 30.

  PMID: 35012793 BACKGROUND

• Jaguga F, Kwobah E. A review of the public sector substance use disorder treatment and prevention systems in Kenya. Subst Abuse Treat Prev Policy. 2020 Jul 20;15(1):47. doi: 10.1186/s13011-020-00291-5.

  PMID: 32690036 BACKGROUND

• Tull MT, Gratz KL. The impact of borderline personality disorder on residential substance abuse treatment dropout among men. Drug Alcohol Depend. 2012 Feb 1;121(1-2):97-102. doi: 10.1016/j.drugalcdep.2011.08.014. Epub 2011 Sep 9.

  PMID: 21907503 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

US (1)