AzTrials
AzTrials

Drug DependencePhase 2NCT04003948

Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification

A Phase 2 study testing Ibogaine Hydrochloride in people with Drug Dependence and Drug Use Disorders, run by International Center for Ethnobotanical Education, Research, and Service at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Methadone is a very long-acting opiate very difficult to detox from. In Spain there are a lot of methadone dependent people in the aftermath of the heroin epidemic of the 1980s. Many have been dependent for more than 15 years and a number of them have a relatively stable life condition (have work, family, housing… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Ibogaine Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
28 Oct 2020to 26 Apr 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Aged between 18 and 60 years.
  • Body weight within normal range (Quetelet's index between 19 and 27) expressed as weight (kg) / height (m2).
  • Normal clinical records and physical examination.
  • Subjects without organic disorders.
  • Laboratory tests (hematology, biochemistry and urinalysis) within the range of normal values, according to the laboratory reference values of the "Hospital Universitari Sant Joan de Reus". Variations may be admitted according to the clinical criteria of the Principal Investigator.
  • Clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (SBP between 100-140 mm Hg/ DBP between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
Show all 9Show fewer
  • Having not participated in another clinical trial in the last 2 months.
  • Free acceptance to participate in the study by obtains signed informed consent form approved by the ethics committee.
  • ECG values within the range of normal values (PR < 240 ms, QRS < 110 ms and QTc < 430 ms in men and QTc < 450 ms in women, and heart rate >50 bpm.

Who cannot join

  • Background of allergy, idiosyncrasy or hypersensitivity to drugs..
  • Intake of any medication within 2 weeks prior taking the study treatment (except for use of paracetamol in short-term symptomatic treatments), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), or any enzymatic inductor or inhibitor before the drug administration.
  • Viral activity for hepatitis B, C or HIV.
  • Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
  • History of severe psychiatric disease like psychosis, bipolar disorder or dissociative disorders, or a high risk to develop them as reported by psychometric questionnaires.
  • Past or current risk of suicide.
Show all 12Show fewer
  • Having undergone major surgery during the previous 6 months before the enrollment.
  • Positive results of the drugs at screening period or the day before starting treatment period: Amphetamines, Cocaine, Ethanol, Opiates (not methadone), and not prescribed Benzodiazepines (positive results may be repeated at the discretion of the PI).
  • Not understanding the nature of the study and potential consequences.
  • 12 lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec for men and ≥450 for women, bradycardia (<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval.
  • Pregnancy or lactation status (females).
  • Not understanding the informed consent.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitari Sant Joan

    Reus, Tarragona, 43204

Other trials in Spain

About this study

Official title: Preliminar Efficacy and Safety of Ibogaine in the Treatment of Methadone

Methadone is a very long-acting opiate very difficult to detox from. In Spain there are a lot of methadone dependent people in the aftermath of the heroin epidemic of the 1980s. Many have been dependent for more than 15 years and a number of them have a relatively stable life condition (have work, family, housing, etc.) and a relatively good health condition in comparison with current heroin users. This Phase-II RCT is a collaboration with the Sant Joan Hospital in Reus, Spain. Twenty patients on the methadone maintenance program will be recruited. Patients will be randomized to two groups: One receiving 6 doses of 100 mg of ibogaine; and the other one receiving ascending doses of ibogaine (100-200-300-400-500-600). Methadone use will be interrupted and for both groups ibogaine will be administered when clinical symptoms of opioid withdrawal appear. After an ibogaine dose, when symptoms of opioid withdrawal appear again, half of the methadone dose used last time will be administered. By doing so, methadone doses will be progressively reduced until no withdrawal symptoms appear.

Being tested
Ibogaine Hydrochloride
Keywords
Ibogaine, Methadone, Drug dependence, Addiction
Medical subject headings
Substance-Related Disorders, Opioid-Related Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ibogaine HydrochlorideDrug

    Fixed or ascending doses of ibogaine will be administered for the treatment of opioid withdrawal syndrome.

Study groups in NCT04003948
Study groupRoleWhat they receive
Fixed doseExperimentalIbogaine Hydrochloride 100 mg on each administration.
Receives: Drug: Ibogaine Hydrochloride
Ascending doseExperimentalIbogaine Hydrochloride on ascending doses (100-200-300-400-500-600).
Receives: Drug: Ibogaine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Methadone dose

    Rate of decrease of methadone dose used

    Measured: 0-6 months

Secondary outcomes (2)

  1. Adverse events

    Description of adverse events found at different doses of ibogaine

    Measured: 0-24 hours

  2. Cardiovascular effects

    Electrocardiogram (QT interval, ST wave)

    Measured: 0-24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2019
  2. Study start28 Oct 2020
  3. Primary completion26 Apr 2024
  4. Study completion26 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04003948
Sponsor's protocol ID
IBO-METAD-001
Status last verified
Jan 2025
First submitted
27 Jun 2019
Last updated
17 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibogaine Hydrochloride in people with Drug Dependence and Drug Use Disorders, run by International Center for Ethnobotanical Education, Research, and Service at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Methadone dose (time frame: 0-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04003948.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in