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Contrave for Post-Bariatric Surgery Weight Management (COR-WR Trial)
COR-WR Trial Summary
This trial is testing whether the drug Contrave, when combined with usual care (dietary and behaviour counselling), can help people who have had bariatric surgery lose weight or prevent weight gain.
COR-WR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOR-WR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COR-WR Trial Design
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- You have been diagnosed with bulimia or anorexia nervosa in the past or currently, as these conditions can increase the risk of seizures.You have not lost more than 20% of your total body weight within 12 months.You have gained back more than 25% of the weight you previously lost.You had a heart attack or stroke within the past 6 months.You are currently taking or planning to take other medications or products for weight loss.You have not lost more than 10% of your total body weight in the past 6 months.You have previously had weight loss surgery called revisional bariatric procedure or duodenal switch.You have a seizure disorder or a history of seizures, or certain conditions that increase the risk of having a seizure. These conditions include head trauma, certain brain abnormalities, tumors or infections in the central nervous system, or metabolic disorders that could be worsened by the medication.You drink alcohol or use drugs excessively, including sedatives, cocaine, or stimulants.You recently stopped drinking alcohol or taking certain medications that can make you sleepy or treat seizures.You cannot take the medication thioridazine while using bupropion because it can increase the risk of serious heart rhythm problems.You have not lost enough weight or have regained a significant amount of weight according to specific guidelines.You have very high blood pressure that is not under control, severe liver or kidney problems, or severe heart disease.You have tried to take your own life in the past, or you have shown signs of wanting to harm yourself within the past month.You have had severe depression or other serious mental health disorders in the past two years.You are currently taking any other medications that contain bupropion (like Wellbutrin, Wellbutrin SR, Wellbutrin XL, or Zyban) because they can increase the risk of seizures.You are currently using long-term pain medication or recently stopped using it.
- Group 1: Contrave 8mg/90mg Extended Release Tablet
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this clinical trial welcome participants aged 80 and above?
"This clinical trial does not allow people aged under 18 or over 65 to take part, yet there are 206 and 644 trials respectively that do accept these age groups."
How many individuals are being recruited to participate in this clinical experiment?
"No longer accepting participants, this trial was published on November 15th 2020 and last updated October 13th 2020. If you are seeking alternative trials, there are currently 956 studies recruiting for obesity related research and 64 studies in search of volunteers to take part in the Contrave 8mg-90mg Extended-Release Tablet clinical trial."
Are there a plethora of Canadian research sites currently conducting this investigation?
"At present, 4 different clinical trial sites are recruiting patients; there is one in Guelph, Kingston and Hamilton respectively. Additionally, there are 4 other centres spread across the region that may be more accessible for those who wish to enroll in this study. Choosing a clinic nearby would reduce any necessary travel burdens associated with participation."
Who can be eligible to join this medical study?
"This clinical trial is accepting two-hundred individuals with obesity, aged between 18 and 65. Applicants must meet the following prerequisites: having lost less than 20% of their total body weight at twelve months; being eighteen years old or above; prior primary Roux en-Y Gastric bypass (RYGB) or Sleeve Gastrectomy (SG) at a surgical Center of Excellence within Ontario Bariatric Network (OBN); losing no more than 10% of Total Body Weight (TBW) in six months; regaining greater than 25% of initial weight loss; having a Body Mass Index (BMI) higher"
What objectives is this experiment attempting to fulfill?
"This clinical trial will assess the Change in absolute weight (Kg) of participants over a 12 month time frame. Secondary targets include Changes in lipid medications, Quality of Life and Health Economic Outcomes as measured with EQ-5D-5L self administered questionnaire, and Average number of days taken for investigational product (Contrave or placebo)."
What indications is Contrave 8Mg-90Mg Extended-Release Tablet employed for?
"Attention Deficit Hyperactivity Disorder (ADHD) can be managed through the use of Contrave 8Mg-90Mg Extended-Release Tablets. Additionally, this medication has been seen to assist with Seasonal Affective Disorder, as well as smoking cessation and withdrawal symptoms related to nicotine addiction."
Does this research currently admit participants?
"At this juncture, this clinical trial is not accepting new candidates. Initially posted on November 15th 2020 and last updated October 13th 2020, if you are searching for other trials there are presently 956 investigations recruiting people with obesity and 64 studies looking to enrol participants in the Contrave 8Mg-90Mg Extended-Release Tablet group."
What is the current regulatory status of Contrave 8Mg-90Mg Extended-Release Tablet?
"Due to the fact that this treatment is Phase 4, which implies it has been approved for public use, Contrave 8Mg-90Mg Extended-Release Tablet's safety was graded a 3 on our assessment scale."
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