Nicotine DependencePhase 2RIMANCT01926626

Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers

A Phase 2 study testing Nicotine Patch and Moclobemide in people with Nicotine Dependence, run by Jed E. Rose at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Nicotine Dependence
What is being tested?: Nicotine Patch and Moclobemide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 3 sitesUnited States
Study dates: Sep 2013to Oct 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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Have no known serious medical conditions;
Female;
Are 18-65 years old;
Smoke an average of at least 20 cigarettes per day;
Have smoked at least one cumulative year;
Have a Fagerstrom Test for Nicotine Dependence score of at least 5;

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Have an expired air carbon monoxide (CO) reading of at least 10ppm;
Able to read and understand English;
Express a desire to quit smoking in the next thirty days.
Potential subjects must agree to avoid the following during their participation in this study:
excessive alcohol consumption;
use of other antidepressants;
general anesthesia;
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;
cimetidine;
Tyramine rich foods;
use of opiate medications.

Who cannot join

Hypertension;
Hypotension with symptoms;
Coronary heart disease;
Lifetime history of heart attack;
Cardiac rhythm disorder;
Chest pains;

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Cardiac (heart) disorder;
Active skin disorder;
Liver or kidney disorder;
Gastrointestinal problems or 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;
Recent, unexplained fainting spells;
Problems giving blood samples;
Diabetes (unless controlled by diet and exercise alone);
Current cancer or treatment for cancer in the past six;
Other major medical condition;
Current psychiatric disease;
Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
Current depression;
Bulimia or anorexia;
Use (within the past 45 days) of psychiatric medications including antidepressants and anti-psychotics;
Use (within the past 30 days) of:
Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),
Experimental (investigational) drugs;
Any medications that are known to affect smoking cessation (e.g. clonidine);
Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days;
Smokes more than one cigar a month.
Alcohol abuse;
Significant adverse reaction to nicotine patches, in the past.
Known hypersensitivity to moclobemide or other MAO-A inhibitors.
Current participation or recent participation (in the past 30 days) in another smoking study at our center or another research facility.
Current participation or recent participation (in the past six months) in another medical research study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Duke Center for Smoking Cessation
Charlotte, North Carolina, 28210
Duke Center forSmoking Cessation
Durham, North Carolina, 27705
Duke Center for Smoking Cessation
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This rationale is based on several findings from previous work: 1) cigarette smoke contains constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2) that severity of depression symptoms after smoking abstinence is correlated with the level of MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women show a greater association between smoking and depression than men and women smokers in our previous trials report smoking to alleviate symptoms of depression to a greater extent than men.

Conditions: Nicotine Dependence
Being tested: Nicotine Patch, Moclobemide
Keywords: Nicotine addiction, Smoking Cessation, Quit Smoking, moclobemide, Nicotine Patch
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.

Nicotine PatchDrug
Also called Nicoderm
Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)
MoclobemideDrug
Also called reversible MAO-A inhibitor
Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)

Study groups in NCT01926626
Study group	Role	What they receive
Nicotine Patch+Moclobemide	Experimental	After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date. Receives: Drug: Nicotine Patch; Drug: Moclobemide

What is being measured

The primary outcome is the main question the study is designed to answer.

Continuous Four-week Abstinence From Smoking
Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).
Measured: Weeks 6-10 post quit day

Secondary outcomes (4)

Point Abstinence From Smoking at Six Months Post Quit
Number of participants who reported 7-day point abstinence from smoking at six months post quit, confirmed by expired air CO.
Measured: 7 day point abstinence from smoking at six months post quit
Continuous Ten Week Abstinence From Smoking
Number of participants who reported continuous ten-week abstinence from smoking (weeks 1-10 post quit day), confirmed by expired air CO.
Measured: 10 weeks post quit day
Percentage of Change in Smoking Withdrawal Symptoms
Withdrawal symptoms will be assessed by questionnaire on Quit Day, 1 week post quit, 3 weeks post quit, 6 weeks post quit,10 weeks post quit and 6 months post quit (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
Measured: Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day
Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.
The initial response to nicotine patch will be assessed by looking at the percent change in expired air carbon monoxide (CO) at the end of week one (Study Visit 2) relative to baseline (Study Visit 1).
Measured: Baseline and 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Oct 2014

First posted21 Aug 2013 (estimated)
Study startSep 2013
Primary completionJul 2014
Study completionOct 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 Nicotine DependenceStudies 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: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01926626
Sponsor's protocol ID: Pro00044174
Other IDs: P50DA027840-01
Acronym: RIMA
Status last verified: Aug 2017
First submitted: 19 Aug 2013
Last updated: 23 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nicotine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
ClinicalTrials.gov ID: NCT01926626
Acronym / sponsor ID: RIMA / Pro00044174
Conditions: Nicotine Dependence
Keywords: Nicotine addiction, Smoking Cessation, Quit Smoking, moclobemide, Nicotine Patch
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Jed E. RoseUniversity, hospital or other
Collaborators: Philip Morris USA, Inc., National Institute on Drug Abuse (NIDA)
Study start: Sep 2013
Primary completion: Jul 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 21 Aug 2013 (estimated)
Results: Posted 29 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nicotine Patch+Moclobemide	Experimental	Drug: Nicotine Patch, Drug: MoclobemideAfter 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Have no known serious medical conditions;
Female;
Are 18-65 years old;
Smoke an average of at least 20 cigarettes per day;
Have smoked at least one cumulative year;

Key exclusion criteria (37 listed)

Hypertension;
Hypotension with symptoms;
Coronary heart disease;
Lifetime history of heart attack;
Cardiac rhythm disorder;

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
Nicotine PatchAlso: NicodermPre-Quit Period: 2 weeks of patch use (21mg/24hr) Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)	Drug	Nicotine Patch+Moclobemide
MoclobemideAlso: reversible MAO-A inhibitorPre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses) Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)	Drug	Nicotine Patch+Moclobemide

Primary outcome

Continuous Four-week Abstinence From Smoking
Time frame: Weeks 6-10 post quit day
Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).

4 secondary outcomes

Point Abstinence From Smoking at Six Months Post Quit
Time frame: 7 day point abstinence from smoking at six months post quit
Continuous Ten Week Abstinence From Smoking
Time frame: 10 weeks post quit day
Percentage of Change in Smoking Withdrawal Symptoms
Time frame: Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day
Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.
Time frame: Baseline and 1 week

Results and safety

Results posted to the registry on 29 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nicotine Patch+Moclobemide	38	16

Primary outcome: Continuous Four-week Abstinence From Smoking

Time frame: Weeks 6-10 post quit day. Number. Unit: participants

Measure	Nicotine Patch+Moclobemide n = 38
Value	7

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were receiving study drugs for twelve weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nicotine Patch+Moclobemide	0 of 37 (0%)	29 of 37 (78.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Social Media Support Groups for Adolescent Vaping Cessation
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Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
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Recruiting
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RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
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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.

Jed E Rose, Ph.D. principal investigator

Duke University

3 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 Nicotine Patch and Moclobemide in people with Nicotine Dependence, run by Jed E. Rose at 3 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 20 inclusion and 37 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 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 29 Jul 2015). 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?

Continuous Four-week Abstinence From Smoking (time frame: Weeks 6-10 post quit day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01926626.

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 Aug 2017.