Substance Abuse Disorder Clinical Trial
Official title:
Exploring the Clinical Trial Journey of Patients in Substance Abuse Disorder Clinical Trials
| NCT number | NCT05881369 |
| Other study ID # | 91257336 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2024 |
| Est. completion date | June 2026 |
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.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | June 2026 |
| Est. primary completion date | June 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Power Life Sciences | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
United States,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of patients who decide to enroll in a substance abuse disorder clinical study. | 3 months | ||
| Primary | Number of substance abuse disorder patients who remain in clinical trial until completion. | 12 months |
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