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An Observational Pre-post Study Evaluating the Safety of Tabernanthe Iboga Exposure

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ClinicalTrials.gov Identifier: NCT04313712
Recruitment Status : Not yet recruiting
First Posted : March 18, 2020
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Nolan R, Stanford University

Brief Summary:
This is an observational study aiming to investigate the risks and consequences of naturalistic tabernanthe iboga exposure in a population with a history of head trauma, combat or blast exposure. We will assess the safety profile of the compound through psychological and cognitive testing. Participants will also have an MRI before and after their exposure to the compound, to examine if there are any brain changes associated with its use. Participants must independently schedule to receive this compound in other countries.

Condition or disease Intervention/treatment
Blast or Combat Exposure Head Injury Trauma Other: tabernanthe iboga exposure in other countries

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Pre-post Study Evaluating the Safety of Tabernanthe Iboga Exposure
Estimated Study Start Date : November 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries

Group/Cohort Intervention/treatment
Participants
All study participants will be observed before and after they receive exposure to tabernanthe iboga in other countries.
Other: tabernanthe iboga exposure in other countries
Participants will be subject to MRI and mood/cognitive testing before and after exposure to tabernanthe iboga in other countries.




Primary Outcome Measures :
  1. Percentage change in WAIS Block Design Subtest scores [ Time Frame: Change will be assessed between baseline and immediate post visits ]
    A measure of visual-spatial and organizational processing abilities, as well as nonverbal problem-solving skills

  2. Percentage change in WAIS Coding Subtest scores [ Time Frame: Change will be assessed between baseline and immediate post visits ]
    A measure of visual-motor coordination, motor and mental speed

  3. Percentage change in WAIS Digit Span Subtest scores [ Time Frame: Change will be assessed between baseline and immediate post visits ]
    A measure of spatial perception, visual abstract processing & problem solving

  4. Percentage change in Trail Making Task A & B scores [ Time Frame: Change will be assessed between baseline and immediate post visits ]
    A 2 part test in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy to measure visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.

  5. Percentage change in Hopkins Verbal Learning Test-Revised scores [ Time Frame: Change will be assessed between baseline and immediate post visits ]
    A test of verbal learning and memory.


Secondary Outcome Measures :
  1. Percent change in the Hamilton Depression Rating Scale (HAMD-21) [ Time Frame: Changes will be measured between baseline, immediate post, and one month post time points. ]
    A provider administered questionnaire used to assess remission and recovery from depression

  2. Percentage change in the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Changes will be measured between baseline, immediate post, and one month post time points. ]
    A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.

  3. Change in the PTSD Symptom Scale Interview-5 scores [ Time Frame: Changes will be measured between the baseline and one month time points. ]
    A clinically administered questionnaire to assess the presence of PTSD (Post Traumatic Stress Disorder) according to DSM-V criteria and assess the severity of PTSD symptoms in individuals with a known trauma history.

  4. Change in responses to the Quality of Life Enjoyment and Satisfaction Questionnaire. [ Time Frame: Changes will be measured between the baseline, immediate post and one month time points. ]
    A self-report measure designed to enable investigators to measure the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning.

  5. Changes in Cognitive Failures Questionnaire scores [ Time Frame: Changes will be measured between baseline and one month post visits ]
    A 25 item self-report questionnaire to assess the frequency with which people experienced cognitive failures, such as absent-mindedness, in everyday life

  6. Structural changes measured by an MRI [ Time Frame: Changes will be measured between baseline and immediate post time points ]
    Using a MRI scan of the brain to measure total gray matter and structural changes in the Ventral diencephalon, frontal lobes, and hippocampus.

  7. Changes in functional connectivity measured by an fMRI [ Time Frame: Changes will be measured between baseline and immediate post time points ]
    Using a fMRI to examine irregularity in the default mode network


Other Outcome Measures:
  1. Percentage change in substance use measured by the Addiction Severity Index-Lite [ Time Frame: Changes will be measured between the baseline and one month post visits ]
    A semi-structured interview to assess substance use change over the past 30 days.

  2. Percentage change in CAPS-5 score [ Time Frame: Changes will be measured between the baseline and one month post visits ]
    A clinically administered instrument to assess PTSD symptoms and severity.

  3. Percentage change in disability functioning measured by the WHODAS [ Time Frame: Changes will be measured between baseline and one month post visits ]
    A 36 item self-report questionnaire to assess disability levels relating to a health condition overall and in 6 different domains: cognition, mobility, self-care, getting along with others, participation in society, and life activities

  4. Percentage change in the Scale of Suicidal Ideation [ Time Frame: Changes will be measured between baseline, immediate post, and one month post visits ]
    A clinician-rating scale presented in a semi-structured interview format designed to assess the intensity, pervasiveness, and characteristics of suicidal ideation in adults.

  5. Change in symptoms measured by the Symptom Checklist 90 Revised (SCL-90-R) [ Time Frame: Changes will be measured between baseline, immediate post, and one month post visits ]
    A 90 item self-report questionnaire to evaluate a broad range of psychological problems and symptoms of psychopathology that is also useful in measuring patient progress or treatment outcomes.

  6. Percentage change in the Five Facets Mindfulness Questionnaire (FFMQ) [ Time Frame: Changes will be measured between baseline, immediate post, and one month post visits ]
    A 39 item self-report questionnaire to assess the 5 facets of mindfulness.

  7. Percentage change in the Forms of Self-Criticising/Attacking & Self-Reassuring Scale (FSCRS) [ Time Frame: Changes will be measured between baseline, immediate post, and one month post visits ]
    A 22 item self-report instrument that measures self-criticism and self-reassurance

  8. Percentage change in the Becks Depression Inventory II (BDI-II) [ Time Frame: Changes will be measured between baseline, immediate post, and one month post visits ]
    A 21 item self-report criteria-referenced assessment for measuring depression severity



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 to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with a history of head trauma, combat or blast exposure that have arranged for tabernanthe iboga exposure in other countries.
Criteria

Inclusion Criteria:

  1. History of head trauma, combat or blast exposure
  2. Arranged for tabernanthe iboga exposure in other countries
  3. Willing and able to travel to Stanford University before and after treatment.
  4. Willing to be video recorded during the consenting process.
  5. Capable of getting an MRI scan.
  6. Male or female, 18-70 years of age, inclusive, at time of screening visit.
  7. Body mass index between 17-35kg/m2

Exclusion Criteria:

  1. History of a neurological disorder (i.e. Parkinson's, epilepsy, dementia, etc.)
  2. History of schizophrenia, schizoaffective disorders, or any history of psychotic symptoms
  3. Abnormal ECG assessed at baseline by a Stanford University medical doctor.
  4. History of cardiovascular problems
  5. History of liver or kidney problems
  6. Has previously been exposed to tabernanthe iboga
  7. Any participation in a clinical trial with an investigational device or drug during study or within 1 month prior to enrollment.
  8. Claustrophobic
  9. Female that is pregnant, breastfeeding, or trying to become pregnant.

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): NCT04313712


Contacts
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Contact: Romina Nejad, MSc 6504973933 rnejad@stanford.edu
Contact: Nick Bassano, MSW 6504973933 nbassano@stanford.edu

Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Nolan Williams, MD Stanford University
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Responsible Party: Nolan R, Assistant Professor, Stanford University, Stanford University
ClinicalTrials.gov Identifier: NCT04313712    
Other Study ID Numbers: 54095
First Posted: March 18, 2020    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021

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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 Nolan R, Stanford University:
blast exposure
combat exposure
head trauma
Additional relevant MeSH terms:
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Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries