No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Other
Participants needed
120 (estimated)
Sponsor
Columbia University · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 65 who are struggling with obesity. Participants will receive dietary counseling and may take a weight loss medication for 40 weeks.
Are You a Good Fit for This Trial?
Must not be takingOpioid analgesicsAntipsychoticsAntidepressantsNaltrexoneDiabetes medications
Rules you outObesity of known endocrine originSevere psychiatric illnessGlaucoma
You may be able to join if
I am between 18 and 65 years old.
I have a BMI between 30 and 50.
I have a BMI between 27 and 29.99 and at least one weight-related health issue.
You may not be able to join if
I have a known hormonal disorder causing my obesity.
I have a history of seizures or serious mental health issues.
I have cardiovascular or kidney disease.
I currently use tobacco regularly.
I am currently pregnant or breastfeeding.
I have high triglycerides over 499 mg/dl.
I have had weight loss surgery before.
I have taken weight loss medications in the last six months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this clinical trial is to understand if genetic variations are associated with the amount of weight loss with diet and while taking an FDA-approved medication for weight loss. The main question\[s\] it aims to answer are:
* In Aim One, the investigators propose to rigorously test the hypothesis that presence of the Taq1A A1+ polymorphism is associated with greater weight loss with NB …
The goal of this clinical trial is to understand if genetic variations are associated with the amount of weight loss with diet and while taking an FDA-approved medication for weight loss. The main question\[s\] it aims to answer are:
* In Aim One, the investigators propose to rigorously test the hypothesis that presence of the Taq1A A1+ polymorphism is associated with greater weight loss with NB compared with the A1- genotype.
* In Aim Two, the investigators will explore other genetic polymorphisms that might influence the efficacy of NB such as the fat mass and obesity-associated (FTO) gene which modulates DRD2 signaling, as carriers of risk alleles in both the FTO and ANKK1 gene demonstrate altered responses to reward-learning tasks associated with negative outcomes.
Participants will be in the study for 40 weeks, which consists of two phases:
1. From baseline to week 12, participants will receive individual nutritional counseling on a calorie restricted diet. This phase includes in-person visits, blood tests, an EKG, vital signs, questionnaires, body weight, and nutritional visits.
2. From week 12 to week 40, participants will continue to receive dietary counseling and will receive treatment with naltrexone/bupropion for 28 weeks. This phase includes in-person and phone visits, blood tests, vital signs, questionnaires, body weight, and nutritional visits.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Men and women ages 18-65 years
* BMI 30-50 kg/m2 or
* BMI 27-29.99 kg/m2 with at least one weight-related comorbidity including controlled hypertension, dyslipidemia, obstructive sleep apnea, or osteoarthritis of a weight-bearing joint.
Exclusion Criteria:
* Obesity of known…
Inclusion Criteria:
* Men and women ages 18-65 years
* BMI 30-50 kg/m2 or
* BMI 27-29.99 kg/m2 with at least one weight-related comorbidity including controlled hypertension, dyslipidemia, obstructive sleep apnea, or osteoarthritis of a weight-bearing joint.
Exclusion Criteria:
* Obesity of known endocrine or hypothalamic origin
* HbA1c \> 6.5%
* Cerebrovascular, cardiovascular, hepatic or renal disease
* History of seizures, serious psychiatric illness or suicide attempts, drug or alcohol misuse within prior 24 months
* Glaucoma
* Current tobacco use on a regular basis
* Use of dopamine agonists, opioid analgesics, antipsychotics, antidepressants, neuroleptics, naltrexone, diabetes medications
* Use of Monoamine oxidase (MAO) inhibitors \< 14 days prior to screening
* Concomitant use of CYP2B6 inhibitors
* History of anorexia nervosa or bulimia
* Previous surgery for obesity
* Weight loss device intervention within prior 2 years
* Currently pregnant or lactating, planning pregnancy or refusal to use birth control when appropriate (Women of childbearing potential will be required to use effective contraception.)
* Blood pressure \> 145/95 (use of anti-hypertensives will be allowed with the exception of verapamil, which can cause hyperprolactinemia)
* Clinically significant thyroid disease
* Triglycerides \> 499 mg/dl
* Current use or use of weight loss medication within prior six months
* Any lifetime weight change deemed significant by Principal Investigator
* An affirmative answer to any question in the Columbia-Suicide Severity Rating Scale
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