Clinical trial NCT05881369: Examining Clinical Research Participation for Substance Abuse Disorder Patient
Official title: Exploring the Clinical Trial Journey of Patients in Substance Abuse Disorder Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Substance Abuse Disorder
Keywords: substance abuse disorder
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Rate of patients who decide to enroll in a substance abuse disorder clinical study.
timeFrame: 3 months
measure: Number of substance abuse disorder patients who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.