This study has been transitioned to CTIS with ID 2024-516645-39-01 check the CTIS register for the current data. The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss(>5…
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
Obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to study the effect of naltrexone/bupropion(Mysimba)
in combination with the BOT module compared to the regular BOT module for 22
weeks, the duration of the regular BOT, on weight loss in patients with weight
regain after bariatric surgery.
Secondary outcome
The secondary objectives are to describe the persistence of therapy of Mysimba
after bariatric surgery; to study the used daily dose of Mysimba in patients
after bariatric surgery; to evaluate eating behaviour in patient with weight
regain after bariatric surgery who used Mysimba compared to patients on the
regular module via the YFAS 2.0 questionair; to study adverse effects of
Mysimba; to monitor and compare weight loss up to 12 months after the start of
Mysimba in both study groups.
Tertiary objective(s):
These are the tertiary objectives:
a) To study bupropion and hydroxybupropion absorption/exposure by measuring
steady-state serum levels in bariatric and compare these with steady-state
serum levels in obese patients on Mysimba therapy who did not undergo bariatric
surgery
b) to correlate bupropion and hydroxybupropion steady-state serum levels with
effectiveness of Mysimba
c) to determine the therapeutic range of bupropion and hydroxybupropion plasma
levels in bariatric and obese patients on Mysimba.
Background summary
Although bariatric surgery is currently the most effective treatment for morbid
obesity, weight regain occurs in 16-37% of the patients (1). Weight regain is
not regularly treated with antiobesity medications (AOMs).
Mysimba (Contrave in US) is a AOM, it is a combination of naltrexone
hydrochloride extended release and bupropion hydrochloride extended release for
the treatment of obesity, and is used with lifestyle modification. Bupropion is
a mild reuptake inhibitor of dopamine and norepinephrine. Naltrexone, an opioid
antagonist has minimum effect on weight loss on its own. Naltrexone is thought
to block the inhibitory effects of opioid receptors activated by the β-
endorphin released in the hypothalamus that stimulates feeding, thus allowing
the inhibitory effects of α-melanocyte stimulating hormone to reduce food
intake. In patients with obesity usage of Naltrexone/Bupropion (NB) results in
up to 8.2% weight loss (2). There is some evidence that also in bariatric
patients with weight regain NB leads to additional weight loss (3, 4).
At the Nederlandse Obesitas Kliniek (NOK) weight regain at follow-up is
currently treated with the Back on Track (BOT) program. The BOT program is an
extra intervention our clinic provides for the patients who have weight regain
after surgery, this is part of our standard care program.
Study objective
This study has been transitioned to CTIS with ID 2024-516645-39-01 check the CTIS register for the current data.
The primary objective is to study the effect of naltrexone/bupropion in
combination with the BOT module on successful weight loss(>5% weight loss)
after 22 weeks in patients with weight regain after bariatric surgery, compared
to the regular BOT module.
Study design
Randomized trail and cohort study
Intervention
Adding Mysimba to the BOT program of the Nederlandse Obesitas Kliniek(NOK) and
one-time venapuncture
Study burden and risks
The burden of participation consists of extra usage of medication which
patients have to administer orally on a daily basis. There will be no extra
consultations to prevent that the medication group will have more guidance
during the BOT programme. The risks consist of gastrointestinal side effects,
anxiety, insomnia, and neurological side effects such as headache, dizziness,
tremor, dysgeusia, lethargy, vertigo and tinnitus. (See SPC paragraph 4.8 for
further explanation) It will be one of the first times Mysimba will be used in
patients post-bariatric surgery, therefore the precise side effects are not
known but assumed to be similar to previous studies. The benefits are possible
better weight loss results compared to the regular BOT module.
There will also be a one-time venipuncture at patients randomised in the
Mysimba group and at patients without bariatric surgery (=control cohort).
Henry Dunantstraat 5
Heerlen 6419 PC
NL
Henry Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, a subject must meet all of the
following criteria:
• Patient is >=18 and <75 years old
• BMI before surgery was >= 35,0 kg/m2
• Patient has undergone a primary banded/non-banded Roux-en-Y gastric bypass
(RYGB) or sleeve gastrectomy (SG)
• Gaining more than 5% weight after reaching plateau phase of lowest weight
To be eligible to participate in the control patient cohort for measuring
bupropion and hydroxybupropion serum levels a subject must meet all of the
following criteria:
• Patient is >=18 and <75 years old
• Patient is obese (BMI > 30 kg/m2)
• Patient on successful Mysimba steady maintenance dose
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Anatomical or surgical abnormalities for which revisional surgery is
indicated.
• Use of the following medication Monoamino-oxidase inbibitors (MAO), selective
serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA),
haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral
medication (HIV)
• Pregnancy or breastfeeding
• Patients suffering from:
o unregulated hypertension
o a tumour in the central nervous system
o severe liver failure
o end stage kidney failure
• Patients suffering from or with a history of insults
• Patients with a history of:
o bipolar disease
o bulimia or anorexia nervosa
• Patients withdrawing from alcohol or benzodiazepines
• Patients who are not able to understand the informed consent form and patient
information.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-516645-39-01 |
| EudraCT | EUCTR2021-002145-15-NL |
| CCMO | NL77771.096.21 |