Smoking CessationPhase 2GanaxoloneNCT01857531
Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate
A Phase 2 study testing Ganaxolone and Nicotine Patch in people with Smoking Cessation, run by Jed E. Rose at 4 sites in United States.
Trial summary
The purpose of this research study is to evaluate whether the investigational drug ganaxolone can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other research studies) for the treatment of seizures and migraines. This drug is considered investigational in the US. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Ganaxolone and Nicotine Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2013to Feb 2014
- 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
- Have no known serious medical conditions;
- Are 18-65 years old;
- Smoke an average of at least 10 cigarettes per day;
- Have smoked at least one cumulative year;
- Have an expired air CO reading of at least 10ppm;
- Able to read and understand English;
Show all 19Show fewer
- Express a desire to quit smoking in the next thirty days.
- Potential subjects must agree to use acceptable contraception during their participation in this study.
- Potential subjects must agree to avoid the following during their participation in this study:
- participation in any other nicotine-related modification strategy outside of this protocol;
- use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;
- use of experimental (investigational) drugs or devices;
- use of illegal drugs;
- use of opiate medications;
- consumption of grapefruit or grapefruit juice for the first six weeks of study participation;
- use of melatonin;
- use of sedating antihistamines for the first six weeks of study participation;
- use of alcohol during the first six weeks of study participation.
- use of benzodiazepines
Who cannot join
- Inability to attend all required experimental sessions;
- Inability to take oral drugs or adhere to medication regimens;
- Hypertension (systolic >140 mm Hg, diastolic >90 mm Hg);
- Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg).
- Coronary heart disease;
- Lifetime history of heart attack;
Show all 44Show fewer
- Clinically significant cardiac rhythm disorder (irregular heart rhythm);
- Chest pains;
- Cardiac (heart) disorder;
- Extensive active skin disorder;
- Liver or kidney disorder;
- Gastrointestinal disease other than gastroesophageal reflux or heartburn;
- Active ulcers in the past 30 days;
- Currently symptomatic lung disorder/disease;
- Brain abnormality;
- Migraine headaches that occur more frequently than once per week;
- History of seizures;
- Recent, unexplained fainting spells;
- Problems giving blood samples;
- Diabetes (unless treated with diet and exercise alone);
- Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
- Other major medical condition;
- Current symptomatic psychiatric disease;
- Current depression;
- Current suicidal ideation or history of suicide attempt (in the past 5 years);
- Pregnant or nursing mothers;
- Use (within the past 30 days) of:
- Illegal drugs (or if the urine drug screen is positive),
- Experimental (investigational) drugs;
- Psychiatric medications including antidepressants, antipsychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
- Corticosteroids;
- Cytochrome P450 341 (CYP3A4) inhibitors and inducers;
- Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
- Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or any other smoking cessation aid.
- Use (within the past 14 days) of:
- dehydroepiandrosterone (DHEA), Pregnenolone or ganaxolone;
- Opiate medications for pain or sleep;
- Benzodiazepines or other drugs with significant sedating or anticholinergic activity;
- Use of more than one cigar a month;
- Regular alcohol use;
- Significant adverse reaction to nicotine patches in the past.
- Significant past adverse reaction to ganaxolone in the past.
- Current participation or recent participation (in the past 30 days) in another smoking study at our center or another research facility.
- Current participation in another research study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke Center for Smoking Cessation
Charlotte, North Carolina, 28210
Duke Center for Smoking Cessation
Durham, North Carolina, 27705
Duke Center for Smoking Cessation
Raleigh, North Carolina, 27609
Duke Center for Smoking Cessation
Winston-Salem, North Carolina, 27103
About this study
The purpose of this research study is to evaluate whether the investigational drug ganaxolone can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other research studies) for the treatment of seizures and migraines. This drug is considered investigational in the US.
Read the detailed description
The purpose of this proof-of-concept study is to evaluate whether expired air carbon monoxide (CO) will be reduced and smoking cessation success rates enhanced for smokers who receive the neurosteroid analog ganaxolone. The trial will be seeking preliminary indications of efficacy and tolerability in the smoking population and allow us to estimate effect sizes for future controlled trials.
- Conditions
- Smoking Cessation
- Being tested
- Ganaxolone, Nicotine Patch
- Keywords
- Smoking Cessation, Quit Smoking, Ganaxolone, Nicotine Patch
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanaxoloneDrug
Pre-Quit Period:
Beginning at Session P1, subjects will receive ganaxolone at a dose of 400mg total daily (200mg bid) for the first three days, 800mg total daily (400mg bid) for the next three days and 1200mg total daily (600mg bid) for the remainder of the first four weeks.
Post-Quit Period:
Following the quit-day, subjects will receive ganaxolone at a dose of (1200mg total daily) for the next week. Down-titration of ganaxolone will begin at post-quit week two. Subjects will receive ganaxolone at a dose of 800mg total daily (400mg bid) to take for three days and 400mg total daily (200mg bid) to take for three.
Nicotine PatchDrug
Also called nicoderm
Pre-Quit Period:
Beginning at Session P2, subjects will receive active 21mg/24h nicotine patches to apply daily for the next two weeks.
Post-Quit Period:
Following the quit-day, subjects will continue to apply active nicotine patches daily for the remainder of the study (21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week).
| Study group | Role | What they receive |
|---|---|---|
| Ganaxolone -- Nicotine Patch | Experimental | Pre-Quit Period:
Ganaxolone -- 400mg daily for the first 3 days, 800mg daily for the next 3 days and 1200mg daily for the remainder of the first 2 wks.
Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.
Post-Quit Period:
Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.
Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk. Receives: Drug: Ganaxolone; Drug: Nicotine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 2
To evaluate the effects of ganaxolone on ad lib smoking by looking at the percent change in expired air CO at the end of week two (relative to baseline).
Measured: Baseline and 2 Weeks
Secondary outcomes (1)
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 4
To evaluate the effects of ganaxolone as an augmentation treatment in conjunction with nicotine patch by looking at the percent change in expired air CO at the end of week four (relative to baseline).
Measured: Baseline and 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionFeb 2014
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 Smoking CessationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jed E. Rose
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Jed E. Rose, Duke University
- Investigators
- Jed E Rose, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857531
- Sponsor's protocol ID
- Pro00041533
- Other IDs
- 1P50DA027840-01A1
- Acronym
- Ganaxolone
- Status last verified
- Sep 2014
- First submitted
- 16 May 2013
- Last updated
- 8 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate
- ClinicalTrials.gov ID
- NCT01857531
- Acronym / sponsor ID
- Ganaxolone / Pro00041533
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, Quit Smoking, Ganaxolone, Nicotine Patch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jed E. RoseUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Posted 8 Sep 2014
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 evaluate whether the investigational drug ganaxolone can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other research studies) for the treatment of seizures and migraines. This drug is considered investigational in the US.
Detailed description
The purpose of this proof-of-concept study is to evaluate whether expired air carbon monoxide (CO) will be reduced and smoking cessation success rates enhanced for smokers who receive the neurosteroid analog ganaxolone. The trial will be seeking preliminary indications of efficacy and tolerability in the smoking population and allow us to estimate effect sizes for future controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ganaxolone -- Nicotine Patch | Experimental | Drug: Ganaxolone, Drug: Nicotine PatchPre-Quit Period: Ganaxolone -- 400mg daily for the first 3 days, 800mg daily for the next 3 days and 1200mg daily for the remainder of the first 2 wks. Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4. Post-Quit Period: Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days. Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Have no known serious medical conditions;
- Are 18-65 years old;
- Smoke an average of at least 10 cigarettes per day;
- Have smoked at least one cumulative year;
- Have an expired air CO reading of at least 10ppm;
Key exclusion criteria (44 listed)
- Inability to attend all required experimental sessions;
- Inability to take oral drugs or adhere to medication regimens;
- Hypertension (systolic >140 mm Hg, diastolic >90 mm Hg);
- Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg).
- Coronary heart disease;
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 |
|---|---|---|
| GanaxolonePre-Quit Period: Beginning at Session P1, subjects will receive ganaxolone at a dose of 400mg total daily (200mg bid) for the first three days, 800mg total daily (400mg bid) for the next three days and 1200mg total daily (600mg bid) for the remainder of the first four weeks. Post-Quit Period: Following the quit-day, subjects will receive ganaxolone at a dose of (1200mg total daily) for the next week. Down-titration of ganaxolone will begin at post-quit week two. Subjects will receive ganaxolone at a dose of 800mg total daily (400mg bid) to take for three days and 400mg total daily (200mg bid) to take for three. | Drug | Ganaxolone -- Nicotine Patch |
| Nicotine PatchAlso: nicodermPre-Quit Period: Beginning at Session P2, subjects will receive active 21mg/24h nicotine patches to apply daily for the next two weeks. Post-Quit Period: Following the quit-day, subjects will continue to apply active nicotine patches daily for the remainder of the study (21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week). | Drug | Ganaxolone -- Nicotine Patch |
Primary outcome
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 2
Time frame: Baseline and 2 Weeks
To evaluate the effects of ganaxolone on ad lib smoking by looking at the percent change in expired air CO at the end of week two (relative to baseline).
1 secondary outcome
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 4
Time frame: Baseline and 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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.
Jed E Rose, Ph.D. principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ganaxolone and Nicotine Patch in people with Smoking Cessation, run by Jed E. Rose at 4 sites 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 19 inclusion and 44 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 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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 8 Sep 2014). 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?
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 2 (time frame: Baseline and 2 Weeks). 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 8 Sep 2014.