ObesityPhase 4COR-WMNCT04589130
Evaluating Contrave for Weight Maintenance in Adults With BMI >= 27 Kg/m2, After 6 Month Behaviour Modification Program.
A Phase 4 study testing Contrave 8Mg-90Mg Extended-Release Tablet in people with Obesity, run by St. Joseph's Healthcare Hamilton at 3 sites in Canada.
Trial summary
Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Contrave 8Mg-90Mg Extended-Release Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Feb 2021to 31 Dec 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Body Mass Index (BMI) of ≥ 27 Kg/m2 and the presence of at least one weight related co-morbidity
- Completed 6 month BCoE behaviour modification program with meal replacements and achieved ≥ 5% weight loss since start of program
- Able and willing to provide signed informed consent
Who cannot join
- Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)
- History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders
- Lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial
- Pregnancy, planned pregnancy in the next 18 months and or breastfeeding
- Does not agree to use highly effective method of birth control if a woman of child bearing potential, for the duration of the study
- Simultaneous or planned use of other weight loss medication (e.g. Saxenda / Orlistat)
Show all 20Show fewer
- Uncontrolled hypertension, severe hepatic impairment, end-stage renal disease
- Myocardial infarction or stroke within 6 months prior to consent
- Renal impairment defined as eGFR < 60
- Seizure disorder or a history of seizures or following conditions that may predispose subjects to risk of seizure: history of head trauma, arteriovenous malformation, central nervous system tumor or infection, or a metabolic disorder that in opinion of the investigator may contraindicate treatment with Contrave and increase risk of seizure (e.g. hypoglycemia, hyponatremia)
- Use of other bupropion-containing products (including, but not limited to, Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban), because the incidence of seizure is dose dependent
- A current or prior diagnosis of bulimia or anorexia nervosa, because of a higher incidence of seizures
- Chronic opioid or opiate agonist (eg, methadone) or partial agonists (eg, buprenorphine) use, or acute opiate withdrawal
- Excessive use of alcohol or sedatives, addiction to cocaine or stimulants (street drugs), or withdrawal from sedatives
- Patients undergoing an abrupt discontinuation of alcohol, benzodiazepines or other sedatives and antiepileptic drugs
- Concomitant administration of monoamine oxidase inhibitors (MAOI) (At least 14 days should elapse between discontinuation of a MAOI and initiation of treatment with Contrave.)
- Concomitant administration of the antipsychotic thioridazine, since bupropion may inhibit thioridazine metabolism, thus causing an increase in thioridazine levels and a potential increased risk of thioridazine-related serious ventricular arrythmias and sudden death
- Known hypersensitivity (or known allergic reaction) to the investigational product(s) or any of its ingredients including lactose
- Current participation in another interventional clinical trial
- Not able to complete subject reported, self administered questionnaires or cannot fully understand all instructions in English
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Guelph General Hospital
Guelph, Ontario, N1E 4J4
St Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 3K7
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
About this study
Official title: Trial Evaluating Effectiveness of Contrave (Naltrexone HCl / Bupropion HCl) for Weight Maintenance in Adults With BMI ≥ 27 Kg/m2, After 6 Month Intensive Behavior Modification Program: Contrave Obesity Trials (COR) Weight Maintenance Study
Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. Presently we do not have any evidence for the use of Contrave for weight maintenance.
The purpose of this study is to demonstrate that in participants who have ≥ 5% weight loss following the completion of a behaviour modification program with meal replacements, Contrave combined with usual care (dietary and behaviour counselling) will significantly improve maintenance of weight loss and promote further weight loss, compared to placebo with usual care.
Read the detailed description
Obesity is associated with increased mortality and morbidity and represents a worldwide epidemic that is increasing in prevalence and remains a significant problem in Canada and a burden on our healthcare system. Maintaining long-term weight loss is the "Achilles' heel" of obesity therapy. Since obesity is considered a chronic disease, we need better interventions than continued calorie restriction and increased physical activity.
Sustained weight loss during the first year is a predictive factor for successful weight loss after 4 years. Clinical trials employing an intensive lifestyle intervention demonstrate that a 5-10% weight loss translates into important reductions in metabolic and cardiovascular risk factors. This benefit however, is quite often mitigated by weight regain which could occur in approximately 50% of patients after 1 year. Further behaviour modification/lifestyle intervention and or pharmacotherapy are the main pillars for treating weight regain or achieving weight maintenance. This study will refine our knowledge and understanding about the most appropriate treatment for weight maintenance.
Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. Presently we do not have any evidence for the use of Contrave for weight maintenance.
This is a 1 year, phase 4, prospective, pragmatic, randomized, double-blind, placebo controlled and crossover, observational study that will be conducted in two 6 month phases, across multiple Bariatric Centres of Excellence (BCoE) in Ontario. The first 6 months is the randomized, double blind, placebo controlled phase and participants will be randomly assigned to receive Contrave with usual care (dietary and behaviour counselling) or placebo with usual care. At 6 months and the end of the blinded phase, all participants will be administered Contrave for the remaining 6 month, open-label phase of the study. In other words, participants randomly allocated to receive Contrave will continue on Contrave for the final 6 months, and participants randomly assigned to placebo will crossover to treatment with Contrave for the final 6 months. All subjects will also continue to receive usual care.
The study includes several follow up visits to assess safety and treatment effects, some in person and others by telephone or video conferencing. Body weight, blood pressure, heart rate, waist circumference, lab tests, and subject completed questionnaires will be collected as part of usual care or for the study. Changes in medications and any possible side effects will also be monitored during the study.
To qualify, men and women must successfully complete the BCoE behaviour modification program and demonstrate ≥ 5% weight loss. All participants will be followed for 1 year with multiple visits to assess safety and treatment effects.
This study aims to demonstrate that in participants who have ≥ 5% weight loss following the completion of a behaviour modification program with meal replacements, Contrave combined with usual care will significantly improve maintenance of weight loss and promote further weight loss, compared to placebo with usual care.
- Conditions
- Obesity
- Being tested
- Contrave 8Mg-90Mg Extended-Release Tablet, Placebo
- Keywords
- weight loss maintenance
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrave 8Mg-90Mg Extended-Release TabletDrug
Also called naltrexone HCl/bupropion HCl
Each Contrave Extended Release Tablet contains 8Mg of naltrexone HCl and 90Mg of bupropion HCl and will be administered orally. Total daily dose is 32Mg / 360Mg.
Participants randomized to the treatment arm will be administered 4 Contrave tablets a day for 1 year (2 tablets taken twice a day).
Participants randomized to the control arm for the first 6 months will crossover and be administered 4 Contrave tablets a day during the second 6 months (2 tablets taken twice a day). All participants will be in the treatment group (Contrave) during the second 6 month phase of the study.
PlaceboDrug
Also called Inactive
Placebo tablets will be administered orally. Participants randomized to the control arm will be administered 4 placebo tablets a day (2 tablets, taken twice a day) during the first 6 months of the study. These participants will crossover to treatment with Contrave for the second 6 months of the study.
| Study group | Role | What they receive |
|---|---|---|
| Contrave 8mg/90mg Extended Release Tablet | Experimental | Group treated with Contrave Extended Release Tablets. Receives: Drug: Contrave 8Mg-90Mg Extended-Release Tablet |
| Placebo | Placebo comparator | Group given placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentage Change in Body Weight
To determine the weight loss maintenance and any further weight loss effect of Contrave with usual care compared to placebo with usual care, in a post behaviour modification program population.
Measured: Week 0 to Week 28
Percentage of participants who maintained their weight
To determine the weight loss maintenance effect of Contrave with usual care compared to placebo with usual care, in post behaviour modification program population (Participants who had a weight regain less than or equal to 3% of weight from Week 0 - 28 will be regarded as maintainers).
Measured: Week 0 to Week 28
Percentage of participants who lost more than of equal to 5% of body weight
To determine any further weight loss effect of Contrave with usual care compared to placebo with usual care, in a post behaviour modification program population.
Measured: Week 0 to Week 28
Secondary outcomes (21)
Mean Percentage Change in Body Weight from baseline to week 52
To determine the weight loss maintenance and any further weight loss effect of Contrave compared to placebo, in a post behaviour modification program population.
Measured: Week 0 to Week 52
Percentage of participants who maintained their weight
To determine the weight loss maintenance effect of Contrave compared to placebo, in a post behaviour modification program population (Participants who had a weight regain less than or equal to 3% of weight from Week 0 - 52 will be regarded as maintainers).
Measured: Week 0 to Week 52
Percentage of participants who lost more than or equal to 5% of body weight
To determine any further weight loss effect of Contrave compared to placebo, in a post behaviour modification program population.
Measured: Week 0 to Week 52
Percentage of participants who lost more than or equal to 10% of body weight
To determine any further weight loss effect of Contrave compared to placebo, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Percentage of participants with weight regain (≥ 5% from baseline)
To determine any weight regain in participants taking Contrave compared to placebo, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Percentage of subjects with weight regain (≥ 10% from baseline)
To determine any weight regain in participants taking Contrave compared to placebo, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Mean Percentage Change in Body Weight in participants who crossed over from placebo to Contrave
To determine any weight loss or maintenance effect of Contrave following placebo control phase.
Measured: Week 28 to Week 52
Change in blood pressure (both systolic and diastolic)
To determine the effect of Contrave compared to placebo on hypertensive control, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Change in fasting lipid profile
To determine the effect of Contrave compared to placebo on total cholesterol, triglycerides, HDL and LDL, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Change in fasting blood glucose
To determine the effect of Contrave compared to placebo on diabetes control, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Changes in impulsivity behaviours from baseline as assessed by UPPS-P Impulsive Behaviour Scale (self administered questionnaire)
To determine the effect of Contrave compared to placebo on impulsivity behaviours, in a post behaviour modification program population. Urgency, Premeditation (lack of), Perserverance (lack of), Sensation Seeking, Positive Urgency (UPPS-P Impulsive Behaviour Scale)
Measured: Week 0 to Week 28 and Week 52
Changes in quality of life and health economic outcomes.
To determine the effect of Contrave compared to placebo on quality of life and health economic outcomes, in a post behaviour modification program population. Assessed by EQ-5D-5L questionnaire.
Measured: Week 0 to Week 28 and Week 52
Percentage of participants who are adherent to pharmacotherapy
To determine the tolerability of Contrave compared to placebo, in a post behaviour modification program setting.
Measured: Week 0 to Week 28 and Week 52
Average number of days participants took investigational product (Contrave or placebo)
To determine the tolerability of Contrave compared to placebo, in a post behaviour modification program setting.
Measured: Week 0 to Week 28 and Week 52
Change in heart rate
To determine the effect of Contrave compared to placebo on heart rate, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Change in HbA1c
To determine the effect of Contrave compared to placebo on diabetes control, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Changes in eating behaviours from baseline as assessed by Eating Disorder Examination Questionnaire (EDE-Q 6.0) (self administered questionnaire)
To determine the effect of Contrave compared to placebo on eating behaviours, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Changes in eating behaviours from baseline as assessed by Yale Food Addiction Scale (YFAS) (self administered questionnaire)
To determine the effect of Contrave compared to placebo on eating behaviours, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Changes in food cravings from baseline as assessed by Favourite Food Craving Scale (FFCS) (self administered questionnaire)
To determine the effect of Contrave compared to placebo on food cravings, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Changes in depression from baseline as assessed by Patient Health Questionnaire 9 (PHQ-9) (self administered questionnaire)
To determine the effect of Contrave compared to placebo on depression and depressive problems, in a post behaviour modification program population.
Measured: Week 0 to Week 28 and Week 52
Changes in risk of suicidality from baseline as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
To determine the effect of Contrave compared to placebo on risk of suicidality, in a post behaviour modification program population.
Measured: Week 0 to Week 12, Week 28 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Feb 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel - 2 arms during first 6 month phase (treatment and placebo control) Crossover - placebo control group crosses over to treatment arm during second 6 months of the study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Principal investigator, Tony Chetty, St. Joseph's Healthcare Hamilton
- Investigators
- Tony Chetty, MD, Principal investigator, The Research Institute at St Joseph's Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589130
- Sponsor's protocol ID
- COR Weight Maintenance Study
- Acronym
- COR-WM
- Status last verified
- Aug 2023
- First submitted
- 5 Oct 2020
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Evaluating Effectiveness of Contrave (Naltrexone HCl / Bupropion HCl) for Weight Maintenance in Adults With BMI ≥ 27 Kg/m2, After 6 Month Intensive Behavior Modification Program: Contrave Obesity Trials (COR) Weight Maintenance Study
- ClinicalTrials.gov ID
- NCT04589130
- Acronym / sponsor ID
- COR-WM / COR Weight Maintenance Study
- Conditions
- Obesity
- Keywords
- weight loss maintenance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. Presently we do not have any evidence for the use of Contrave for weight maintenance.
The purpose of this study is to demonstrate that in participants who have ≥ 5% weight loss following the completion of a behaviour modification program with meal replacements, Contrave combined with usual care (dietary and behaviour counselling) will significantly improve maintenance of weight loss and promote further weight loss, compared to placebo with usual care.
Detailed description
Obesity is associated with increased mortality and morbidity and represents a worldwide epidemic that is increasing in prevalence and remains a significant problem in Canada and a burden on our healthcare system. Maintaining long-term weight loss is the "Achilles' heel" of obesity therapy. Since obesity is considered a chronic disease, we need better interventions than continued calorie restriction and increased physical activity.
Sustained weight loss during the first year is a predictive factor for successful weight loss after 4 years. Clinical trials employing an intensive lifestyle intervention demonstrate that a 5-10% weight loss translates into important reductions in metabolic and cardiovascular risk factors. This benefit however, is quite often mitigated by weight regain which could occur in approximately 50% of patients after 1 year. Further behaviour modification/lifestyle intervention and or pharmacotherapy are the main pillars for treating weight regain or achieving weight maintenance. This study will refine our knowledge and understanding about the most appropriate treatment for weight maintenance.
Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. Presently we do not have any evidence for the use of Contrave for weight maintenance.
This is a 1 year, phase 4, prospective, pragmatic, randomized, double-blind, placebo controlled and crossover, observational study that will be conducted in two 6 month phases, across multiple Bariatric Centres of Excellence (BCoE) in Ontario. The first 6 months is the randomized, double blind, placebo controlled phase and participants will be randomly assigned to receive Contrave with usual care (dietary and behaviour counselling) or placebo with usual care. At 6 months and the end of the blinded phase, all participants will be administered Contrave for the remaining 6 month, open-label phase of the study. In other words, participants randomly allocated to receive Contrave will continue on Contrave for the final 6 months, and participants randomly assigned to placebo will crossover to treatment with Contrave for the final 6 months. All subjects will also continue to receive usual care.
The study includes several follow up visits to assess safety and treatment effects, some in person and others by telephone or video conferencing. Body weight, blood pressure, heart rate, waist circumference, lab tests, and subject completed questionnaires will be collected as part of usual care or for the study. Changes in medications and any possible side effects will also be monitored during the study.
To qualify, men and women must successfully complete the BCoE behaviour modification program and demonstrate ≥ 5% weight loss. All participants will be followed for 1 year with multiple visits to assess safety and treatment effects.
This study aims to demonstrate that in participants who have ≥ 5% weight loss following the completion of a behaviour modification program with meal replacements, Contrave combined with usual care will significantly improve maintenance of weight loss and promote further weight loss, compared to placebo with usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel - 2 arms during first 6 month phase (treatment and placebo control) Crossover - placebo control group crosses over to treatment arm during second 6 months of the study
| Arm | Type | Receives |
|---|---|---|
| Contrave 8mg/90mg Extended Release Tablet | Experimental | Drug: Contrave 8Mg-90Mg Extended-Release TabletGroup treated with Contrave Extended Release Tablets. |
| Placebo | Placebo comparator | Drug: PlaceboGroup given placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- Body Mass Index (BMI) of ≥ 27 Kg/m2 and the presence of at least one weight related co-morbidity
- Completed 6 month BCoE behaviour modification program with meal replacements and achieved ≥ 5% weight loss since start of program
- Able and willing to provide signed informed consent
Key exclusion criteria (20 listed)
- Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)
- History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders
- Lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial
- Pregnancy, planned pregnancy in the next 18 months and or breastfeeding
- Does not agree to use highly effective method of birth control if a woman of child bearing potential, for the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrave 8Mg-90Mg Extended-Release TabletAlso: naltrexone HCl/bupropion HClEach Contrave Extended Release Tablet contains 8Mg of naltrexone HCl and 90Mg of bupropion HCl and will be administered orally. Total daily dose is 32Mg / 360Mg. Participants randomized to the treatment arm will be administered 4 Contrave tablets a day for 1 year (2 tablets taken twice a day). Participants randomized to the control arm for the first 6 months will crossover and be administered 4 Contrave tablets a day during the second 6 months (2 tablets taken twice a day). All participants will be in the treatment group (Contrave) during the second 6 month phase of the study. | Drug | Contrave 8mg/90mg Extended Release Tablet |
| PlaceboAlso: InactivePlacebo tablets will be administered orally. Participants randomized to the control arm will be administered 4 placebo tablets a day (2 tablets, taken twice a day) during the first 6 months of the study. These participants will crossover to treatment with Contrave for the second 6 months of the study. | Drug | Placebo |
Primary outcome
Mean Percentage Change in Body Weight
Time frame: Week 0 to Week 28
To determine the weight loss maintenance and any further weight loss effect of Contrave with usual care compared to placebo with usual care, in a post behaviour modification program population.
Percentage of participants who maintained their weight
Time frame: Week 0 to Week 28
To determine the weight loss maintenance effect of Contrave with usual care compared to placebo with usual care, in post behaviour modification program population (Participants who had a weight regain less than or equal to 3% of weight from Week 0 - 28 will be regarded as maintainers).
Percentage of participants who lost more than of equal to 5% of body weight
Time frame: Week 0 to Week 28
To determine any further weight loss effect of Contrave with usual care compared to placebo with usual care, in a post behaviour modification program population.
21 secondary outcomes
Mean Percentage Change in Body Weight from baseline to week 52
Time frame: Week 0 to Week 52
Percentage of participants who maintained their weight
Time frame: Week 0 to Week 52
Percentage of participants who lost more than or equal to 5% of body weight
Time frame: Week 0 to Week 52
Percentage of participants who lost more than or equal to 10% of body weight
Time frame: Week 0 to Week 28 and Week 52
Percentage of participants with weight regain (≥ 5% from baseline)
Time frame: Week 0 to Week 28 and Week 52
Percentage of subjects with weight regain (≥ 10% from baseline)
Time frame: Week 0 to Week 28 and Week 52
Mean Percentage Change in Body Weight in participants who crossed over from placebo to Contrave
Time frame: Week 28 to Week 52
Change in blood pressure (both systolic and diastolic)
Time frame: Week 0 to Week 28 and Week 52
Change in fasting lipid profile
Time frame: Week 0 to Week 28 and Week 52
Change in fasting blood glucose
Time frame: Week 0 to Week 28 and Week 52
Changes in impulsivity behaviours from baseline as assessed by UPPS-P Impulsive Behaviour Scale (self administered questionnaire)
Time frame: Week 0 to Week 28 and Week 52
Changes in quality of life and health economic outcomes.
Time frame: Week 0 to Week 28 and Week 52
Percentage of participants who are adherent to pharmacotherapy
Time frame: Week 0 to Week 28 and Week 52
Average number of days participants took investigational product (Contrave or placebo)
Time frame: Week 0 to Week 28 and Week 52
Change in heart rate
Time frame: Week 0 to Week 28 and Week 52
Change in HbA1c
Time frame: Week 0 to Week 28 and Week 52
Changes in eating behaviours from baseline as assessed by Eating Disorder Examination Questionnaire (EDE-Q 6.0) (self administered questionnaire)
Time frame: Week 0 to Week 28 and Week 52
Changes in eating behaviours from baseline as assessed by Yale Food Addiction Scale (YFAS) (self administered questionnaire)
Time frame: Week 0 to Week 28 and Week 52
Changes in food cravings from baseline as assessed by Favourite Food Craving Scale (FFCS) (self administered questionnaire)
Time frame: Week 0 to Week 28 and Week 52
Changes in depression from baseline as assessed by Patient Health Questionnaire 9 (PHQ-9) (self administered questionnaire)
Time frame: Week 0 to Week 28 and Week 52
Changes in risk of suicidality from baseline as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Week 0 to Week 12, Week 28 and Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Chetty, MD principal investigator
The Research Institute at St Joseph's Hamilton
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contrave 8Mg-90Mg Extended-Release Tablet in people with Obesity, run by St. Joseph's Healthcare Hamilton at 3 sites in Canada.
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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Mean Percentage Change in Body Weight (time frame: Week 0 to Week 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2023.