Nicotine DependencePhase 2NCT01188967
Effectiveness of GSK598809, a Selective D3 Antagonist, Added to CBT and NRT for Smoking Cessation and Relapse Prevention
A Phase 2 study testing GSK598809 in people with Nicotine Dependence, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to find out if an investigational drug, GSK598809 can help people who have very recently quit smoking; the investigators want to find out if continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- GSK598809
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnant or able to become pregnant and not willing to use approved contraception.
- Breastfeeding or planning to breastfeed during the study or lactating within the month prior to enrollment.
- Has any of the following medical conditions/situations:
- Severe or unstable COPD or Asthma Bundle branch block Evidence of active neurological disease, including current migraine headaches requiring chronic treatment.
- Clinically significant renal dysfunction eGFR <60 History of any tissue/organ transplant Total fasting cholesterol or triglycerides greater than 2 times the upper limit of normal Previous or current history of cancer, including skin cancer Serum Prolactin > 25 ng/mL at the time of screening or randomization Evidence of chronic liver disease or ALT, AST, or alkaline phosphatase values >1.5 times the upper limit of normal, total bilirubin values > the upper limit of normal, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis, Child-Pugh Class B/C) Positive screening Hepatitis B surface antigen or Hepatitis C antibody, or positive result within 3 months of screening A positive test for HIV antibody Any other unstable cardiovascular or pulmonary disease, or medication for said diseases has been changed in the past 3 months, or the medication is listed on the excluded medications list.
- Is unlikely to cooperate or unable to follow all of the procedures outlined in the protocol
Show all 24Show fewer
- Use of tobacco-containing products other than cigarettes (e.g., cigar, pipe) and unwilling to discontinue use of these on the quit date.
- Abuse or dependence of any substance other than nicotine or caffeine in the past 6 months.
- Diagnosis of major depressive disorder in the past 6 months.
- Lifetime DSM-IV diagnosis of organic mental disorder, schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder or psychotic disorders not elsewhere classified as determined by SCID.
- History of multiple adverse drug reactions.
- Has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Urine positive for drugs of abuse at screening and any pre-randomization visit.
- Alcohol abuse, defined as self-report of an average weekly intake of > 21 standard drinks or an average daily intake of >3 standard drinks (males) or an average weekly intake of >14 standard drinks or an average daily intake of >2 standard drinks (females) in the past 6 months. One unit is equivalent to a half-pint (220mL) of beer or one (25mL) measure of spirits or one glass (125mL) of wine. Participants will be advised to minimize alcohol consumption during the study, as there may be the potential for additive effects of study medication and alcohol, potentially causing greater sedation and feeling of intoxication than alcohol alone.
- Has been exposed to more than four new chemical entities within 12 months prior to the first day of the double-blind treatment phase.
- Has used non-prescription drugs or herbal medicines that are centrally active within 14 days prior to the first dosing day, with the exception of non-daily PRN use of acetaminophen or ibuprofen and daily use of vitamins.
- Has ever used chronic antipsychotic, anti-epileptic, or mood stabilizing medication; has used anti-anxiety medication, antidepressant medication, or prescription sedatives or hypnotics within 5 half lives or two weeks of randomization, whichever is greater.
- Has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator makes participation contraindicated.
- Has donated blood such that participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56-day period.
- Has a failed smoking cessation attempt using adequate smoking cessation pharmacotherapy within the last month.
- Current Axis II DSM-IV diagnosis that may interfere with the conduct of the study.
- Personal or family history of long QT syndrome, personal or family history of unexplained syncope, or family history of unexplained sudden death.
- Currently using, or have used within the month prior to study start, any drug that can cause prolongation of the QT interval.
- Currently using any HMG CoA Reductase Inhibitor.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Double-Blind, Placebo-Controlled, Parallel Group Design Trial of the Selective D3 Antagonist, GSK598809, Added to CBT and NRT for Smoking Cessation and Prevention of Very Early Relapse to Smoking
The purpose of this research study is to find out if an investigational drug, GSK598809 can help people who have very recently quit smoking; the investigators want to find out if continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. To relapse means you "fall back" into smoking again after quitting. The investigators also want to find out if GSK598809 is safe to take without causing too many side effects.
Read the detailed description
We propose to conduct a first test of the effect of the dopamine D3 receptor antagonist, GSK598809, on smoking behavior when treatment is started immediately following the quit date. To do this, we propose to conduct a 10-week, double-blind, placebo-controlled, proof of mechanism study in 90 adult smokers. Participants will complete baseline evaluations. They will receive manualized cognitive behavioral therapy, beginning prior to the quit date, and will set a quit date for the day before their week 2 study visit. They will be given short acting NRT (gum or lozenge) to use on their quit date. They will be asked to arrive for the week 2 visit with 18-24 hours abstinence and an expired air CO ≤ 10ppm. Those who do so will be randomly assigned to receive double blind GSK598809 or identical placebo for six weeks. Participants will begin double blind GSK598809 or placebo, both in conjunction with prn NRT up to 8 mg per day for two weeks. Participants will then continue double blind GSK598809 or placebo in the absence of NRT for 4 more weeks. At the end of this period (week 8 of the study), participants will then be followed 2 weeks after discontinuation of double blind treatment to complete the 10 weeks of the study.
- Conditions
- Nicotine Dependence
- Being tested
- GSK598809, Placebo
- Keywords
- Drugs, Investigational, Nicotine Dependence, Therapies for Relapse to Nicotine, Relapse Prevention, Smoking Cessation, Nicotine Cessation Therapies
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK598809Drug
Oral dose of 60 mg/day for a treatment period six weeks
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GSK598809 | Experimental | Active medication Receives: Drug: GSK598809 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-week, Continuous Tobacco Abstinence at the End of the 6-week, Double Blind, Treatment Phase
The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 4-week, continuous tobacco abstinence than those assigned to identical placebo at the end of the 6-week, double blind, treatment phase. Four-week continuous abstinence will be defined as Timeline Followback Calendar confirmation at study visit of smoking no cigarettes in the past 7 days, and expired air CO<10ppm for 4 consecutive weeks (the last 4 weeks of the randomized phase)
Measured: Week 8 of the study
Secondary outcomes (3)
7-day, Point-prevalence Tobacco Abstinence at the End of the First Week of Exposure to GSK598809/Placebo
The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo at the end of the first week of exposure to GSK598809/placebo.
Measured: Week 3 of the study
7-day, Point-prevalence Tobacco Abstinence at the End of 6 Weeks Exposure to GSK598809/Placebo
The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo at the end of 6 weeks exposure to GSK598809/placebo.
Measured: Week 8 of the study
Number of Participants With 7-day, Point-prevalence Tobacco Abstinence 2-weeks After Discontinuation of Double Blind Study Medications
The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo two weeks after discontinuation of double blind study medications.
7-day, Point-prevalence tobacco abstinence was defined as not smoking for the 7 consecutive days before this visit after discontinuation of double blind study medications
Measured: Week 10 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Mclean Hospital, GlaxoSmithKline
- Responsible party
- Principal investigator, Maurizio Fava, MD, Massachusetts General Hospital
- Investigators
- Maurizio Fava, MD, Principal investigator, Massachusetts General HospitalEden Evins, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188967
- Sponsor's protocol ID
- NIDA-19378-5
- Other IDs
- U01DA019378
- Status last verified
- Jan 2017
- First submitted
- 5 Aug 2010
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Parallel Group Design Trial of the Selective D3 Antagonist, GSK598809, Added to CBT and NRT for Smoking Cessation and Prevention of Very Early Relapse to Smoking
- ClinicalTrials.gov ID
- NCT01188967
- Acronym / sponsor ID
- NIDA-19378-5
- Conditions
- Nicotine Dependence
- Keywords
- Drugs, Investigational, Nicotine Dependence, Therapies for Relapse to Nicotine, Relapse Prevention, Smoking Cessation, Nicotine Cessation Therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Mclean Hospital, GlaxoSmithKline
- Study start
- Aug 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Posted 9 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to find out if an investigational drug, GSK598809 can help people who have very recently quit smoking; the investigators want to find out if continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. To relapse means you "fall back" into smoking again after quitting. The investigators also want to find out if GSK598809 is safe to take without causing too many side effects.
Detailed description
We propose to conduct a first test of the effect of the dopamine D3 receptor antagonist, GSK598809, on smoking behavior when treatment is started immediately following the quit date. To do this, we propose to conduct a 10-week, double-blind, placebo-controlled, proof of mechanism study in 90 adult smokers. Participants will complete baseline evaluations. They will receive manualized cognitive behavioral therapy, beginning prior to the quit date, and will set a quit date for the day before their week 2 study visit. They will be given short acting NRT (gum or lozenge) to use on their quit date. They will be asked to arrive for the week 2 visit with 18-24 hours abstinence and an expired air CO ≤ 10ppm. Those who do so will be randomly assigned to receive double blind GSK598809 or identical placebo for six weeks. Participants will begin double blind GSK598809 or placebo, both in conjunction with prn NRT up to 8 mg per day for two weeks. Participants will then continue double blind GSK598809 or placebo in the absence of NRT for 4 more weeks. At the end of this period (week 8 of the study), participants will then be followed 2 weeks after discontinuation of double blind treatment to complete the 10 weeks of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK598809 | Experimental | Drug: GSK598809Active medication |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- Pregnant or able to become pregnant and not willing to use approved contraception.
- Breastfeeding or planning to breastfeed during the study or lactating within the month prior to enrollment.
- Has any of the following medical conditions/situations:
- Severe or unstable COPD or Asthma Bundle branch block Evidence of active neurological disease, including current migraine headaches requiring chronic treatment.
- Clinically significant renal dysfunction eGFR <60 History of any tissue/organ transplant Total fasting cholesterol or triglycerides greater than 2 times the upper limit of normal Previous or current history of cancer, including skin cancer Serum Prolactin > 25 ng/mL at the time of screening or randomization Evidence of chronic liver disease or ALT, AST, or alkaline phosphatase values >1.5 times the upper limit of normal, total bilirubin values > the upper limit of normal, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis, Child-Pugh Class B/C) Positive screening Hepatitis B surface antigen or Hepatitis C antibody, or positive result within 3 months of screening A positive test for HIV antibody Any other unstable cardiovascular or pulmonary disease, or medication for said diseases has been changed in the past 3 months, or the medication is listed on the excluded medications list.
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 |
|---|---|---|
| GSK598809Oral dose of 60 mg/day for a treatment period six weeks | Drug | GSK598809 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
4-week, Continuous Tobacco Abstinence at the End of the 6-week, Double Blind, Treatment Phase
Time frame: Week 8 of the study
The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 4-week, continuous tobacco abstinence than those assigned to identical placebo at the end of the 6-week, double blind, treatment phase. Four-week continuous abstinence will be defined as Timeline Followback Calendar confirmation at study visit of smoking no cigarettes in the past 7 days, and expired air CO<10ppm for 4 consecutive weeks (the last 4 weeks of the randomized phase)
3 secondary outcomes
7-day, Point-prevalence Tobacco Abstinence at the End of the First Week of Exposure to GSK598809/Placebo
Time frame: Week 3 of the study
7-day, Point-prevalence Tobacco Abstinence at the End of 6 Weeks Exposure to GSK598809/Placebo
Time frame: Week 8 of the study
Number of Participants With 7-day, Point-prevalence Tobacco Abstinence 2-weeks After Discontinuation of Double Blind Study Medications
Time frame: Week 10 of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Maurizio Fava, MD principal investigator
Massachusetts General Hospital
Eden Evins, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK598809 in people with Nicotine Dependence, run by Massachusetts General Hospital 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 0 inclusion and 24 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 Feb 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
4-week, Continuous Tobacco Abstinence at the End of the 6-week, Double Blind, Treatment Phase (time frame: Week 8 of the study). 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 Feb 2017.