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Long-Term Varenicline for Tobacco Use Disorder
Study Summary
This trial will test two interventions: directly observed medication therapy, and long-term therapy with varenicline among 450 smokers with opioid use disorder recruited from community-based, outpatient opioid treatment programs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not used varenicline in the last 30 days.I have a history of seizures.I have been diagnosed with an alcohol use disorder.I currently smoke 5 or more cigarettes a day and have smoked at least 100 in my lifetime.I can participate in interviews in English or Spanish.My kidney function is low, with a creatinine clearance under 30 mL/min.I am currently diagnosed with major depression, bipolar disorder, or a psychotic disorder.I am not pregnant, breastfeeding, or planning to become pregnant.I have not had an AIDS-defining illness or been hospitalized for it in the past 6 months.I do not have severe liver disease with symptoms like poor blood clotting or low albumin.I haven't had serious heart issues like a heart attack or unstable angina in the last 6 months.I am 18 years old or older.I visit the clinic 1-6 times a week for methadone or buprenorphine.I have been in an opioid treatment program for at least 3 months.I agree to use birth control during the trial.My methadone or buprenorphine dose has been stable for two weeks.I have attempted suicide in the last year.I am currently having thoughts about harming myself.I want to quit smoking.I have severe asthma or COPD and needed oxygen or was hospitalized recently.
- Group 1: Directly Observed Therapy
- Group 2: Short-Term Varenicline
- Group 3: Self Administered Therapy
- Group 4: Long-Term Varenicline
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 trial require additional participants at the present time?
"Data hosted on clinicaltrials.gov verifies that this trial is presently recruiting participants, with the original post backdated to October 25th 2018 and the latest update being logged in May 19th 2022."
How many individuals can participate in this investigation?
"Indeed, the clinicaltrials.gov website confirms that this investigation is still recruiting individuals as of May 19th 2022. It was first advertised on October 25th 2018 and requires 450 people from one trial site to take part in the study."
What other investigations have looked into the efficacy of Directly Observed Therapy?
"Presently, there are 26 active clinical trials researching Directly Observed Therapy with 4 of them in Phase 3. Of these experiments, some originate from Charleston, South carolina while the remainder is located across 69 trial sites."
Does the FDA sanction Directly Observed Therapy as an accepted procedure?
"Directly Observed Therapy was assigned a score of 3 due to the advanced stage of this study, as it has been approved by regulatory bodies."
What is the main aim of this experiment?
"Over the course of 24 weeks, investigators will measure initial abstinence as their primary outcome and nicotine dependence (as quantified by Fagerstrom test), quality of life (assessed using Medical Outcomes Study Short Form 12)and durability of tobacco abstinence (CO-verified 7-day point prevalence at week 52)."
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