Effectiveness of GSK598809, a Selective D3 Antagonist, Added to CBT and NRT for Smoking Cessation and Relapse Prevention

NCT01188967 | Completed Phase 2 Results DMC

• 2 other identifiers: NIDA-19378-5U01DA019378
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nicotine Dependence

Keywords

Drugs, Investigational; Nicotine Dependence; Therapies for Relapse to Nicotine; Relapse Prevention; Smoking Cessation; Nicotine Cessation Therapies

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  Week 3 of the study

• 7-day, Point-prevalence Tobacco Abstinence at the End of 6 Weeks Exposure to GSK598809/Placebo

  Week 8 of the study

• Number of Participants With 7-day, Point-prevalence Tobacco Abstinence 2-weeks After Discontinuation of Double Blind Study Medications

  Week 10 of the study

Study Arms (2)

GSK598809

EXPERIMENTAL

Active medication

Drug: GSK598809

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

GSK598809 DRUG

Oral dose of 60 mg/day for a treatment period six weeks

GSK598809

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Mclean Hospital: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

GSK598809

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Results Point of Contact

• Title: Maurizio Fava M.D.
• Organization: Massachusetts General Hospital

mfava@partners.org

617-724-2513

Study Officials

• Maurizio Fava, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Eden Evins, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maurizio Fava, M.D.

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 26, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 23, 2017
• Results First Posted: January 9, 2017

Record last verified: 2017-01

Locations

US (1)