Chronic PainPhase 1NCT01436474
Pilot Study of Varenicline to Treat Opioid Dependence
A Phase 1 study testing Varenicline in people with Chronic Pain and Opioid Dependence, run by Mayo Clinic at 1 site in United States.
Trial summary
The objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Pain, Opioid Dependence
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2012
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>=21 years
- Use of opioids at admission to PRC, with daily morphine equivalent dose>=60mg
- Be able and willing to participate fully in all aspects of the study including one month follow-up after completion of PRC
- Ability to provide informed consent
Who cannot join
- Currently using varenicline or other pharmacotherapy for nicotine dependence
- Currently pregnant, lactating, or likely to become pregnant during the trial and not willing to use an acceptable form of contraception;
- History of a major cardiovascular event in the past 6 months including unstable angina, acute myocardial infarction, stroke, or coronary angioplasty;
- Known varenicline allergy
- Use of any medication (e.g., methadone, Suboxone) as maintenance therapy for opiate addiction
- Identification of illicit drugs (e.g., marijuana, cocaine) on the baseline urine toxicology screen
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Role of Varenicline in Treating Opioid Dependence: A Pilot Study
The objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.
- Conditions
- Chronic Pain, Opioid Dependence
- Being tested
- Varenicline, Placebo
- Keywords
- Varenicline, Chantix, Chronic Pain, Opioid dependence
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.
PlaceboDrug
Also called chantix
Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | We will be comparing Varenicline to placebo in a single-blinded placebo controlled, randomized study Receives: Drug: Varenicline |
| Placebo | Placebo comparator | We will be using a placebo in a randomized, controlled, single-blinded trial to look at varenicline for the indication of facilitating opioid tapering in opioid-dependent patients with chronic pain. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of opioid withdrawal symptoms
During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning
Measured: 45 days
Assessment of cravings at one month following opioid tapering
During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W. Michael Hooten, Mayo Clinic
- Investigators
- William Hooten, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436474
- Sponsor's protocol ID
- 11-002062
- Status last verified
- Jan 2013
- First submitted
- 3 Jun 2011
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Varenicline in Treating Opioid Dependence: A Pilot Study
- ClinicalTrials.gov ID
- NCT01436474
- Acronym / sponsor ID
- 11-002062
- Conditions
- Chronic Pain, Opioid Dependence
- Keywords
- Varenicline, Chantix, Chronic Pain, Opioid dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Sep 2011 (estimated)
- 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.
The objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: VareniclineWe will be comparing Varenicline to placebo in a single-blinded placebo controlled, randomized study |
| Placebo | Placebo comparator | Drug: PlaceboWe will be using a placebo in a randomized, controlled, single-blinded trial to look at varenicline for the indication of facilitating opioid tapering in opioid-dependent patients with chronic pain. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>=21 years
- Use of opioids at admission to PRC, with daily morphine equivalent dose>=60mg
- Be able and willing to participate fully in all aspects of the study including one month follow-up after completion of PRC
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Currently using varenicline or other pharmacotherapy for nicotine dependence
- Currently pregnant, lactating, or likely to become pregnant during the trial and not willing to use an acceptable form of contraception;
- History of a major cardiovascular event in the past 6 months including unstable angina, acute myocardial infarction, stroke, or coronary angioplasty;
- Known varenicline allergy
- Use of any medication (e.g., methadone, Suboxone) as maintenance therapy for opiate addiction
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 |
|---|---|---|
| VareniclineAlso: ChantixPatients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. | Drug | Varenicline |
| PlaceboAlso: chantixPatients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. | Drug | Placebo |
Primary outcome
assessment of opioid withdrawal symptoms
Time frame: 45 days
During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning
Assessment of cravings at one month following opioid tapering
Time frame: 45 days
During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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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.
William Hooten, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Varenicline in people with Chronic Pain and Opioid Dependence, run by Mayo Clinic at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
assessment of opioid withdrawal symptoms (time frame: 45 days). The study lists 2 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 23 Jan 2013.