Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate

NCT01857531 | Completed Phase 2 Results DMC

• 2 other identifiers: Pro000415331P50DA027840-01A1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Smoking Cessation

Keywords

Smoking Cessation; Quit Smoking; Ganaxolone; Nicotine Patch

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and 2 Weeks

Secondary Outcomes (1)

• Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 4

  Baseline and 4 Weeks

Other Outcomes (4)

• Number of Participants Completing Continuous 2-week Abstinence From Smoking

  2 Weeks post quit

• Number of Participants Completing Point Abstinence From Smoking Two Weeks After Quitting

  7 day point abstinence from smoking at 2 weeks post quit

• Number of Participants Completing Continuous 6-week Abstinence From Smoking

  6 Weeks post quit

Study Arms (1)

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.

Drug: Ganaxolone; Drug: Nicotine Patch

Interventions

Ganaxolone DRUG

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.

Ganaxolone -- Nicotine Patch

Nicotine Patch DRUG

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).

Also known as: nicoderm

Ganaxolone -- Nicotine Patch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jed E. Rose: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Duke Center for Smoking Cessation

Charlotte, North Carolina, 28210, United States

Location

Duke Center for Smoking Cessation

Durham, North Carolina, 27705, United States

Location

Duke Center for Smoking Cessation

Raleigh, North Carolina, 27609, United States

Location

Duke Center for Smoking Cessation

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

ganaxolone; Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Jed E. Rose
• Organization: Duke Center for Smoking Cessation

jed.rose@duke.edu

919-668-5055

Study Officials

• Jed E Rose, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 20, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 8, 2014
• Results First Posted: September 8, 2014

Record last verified: 2014-09

Locations

US (4)