Guanfacine Clinical Trial for Smoking Cessation

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02051309
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 121
• Location: 1
• Arms: 2
• Duration (Months): 80.1
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Adult daily smokers motivated to quit smoking will be randomized to extended-release guanfacine (6mg/day) or placebo and will enroll in an 8-week treatment period combining medication with brief behavioral support. The investigators hypothesize that the active dose of guanfacine compared to placebo will increase rates of prolonged smoking abstinence at the end of the 8-week treatment phase.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Drug: Guanfacine; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase-II Clinical Trial Evaluating Guanfacine for Smoking Cessation
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Nov 1, 2020
• Actual Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guanfacine 6mg/day ER Guanfacine 6mg/day extended release	Drug: Guanfacine; 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication. Follow up at 1 month, 2 months and 6 months.; Other Names: Intuniv
Placebo Comparator: Placebo Placebo matching capsule	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Rates of Prolonged Smoking Abstinence [Week 3 to week 8 during 8-week treatment phase]

   Prolonged smoking abstinence defined as no relapse in week 3 to week 8, in participants with available outcome data during weeks 3 to 8.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 18-65

• Able to read, write and comprehend English

• Smoker

• Able to take oral medications and willing to adhere to a medication regimen

• Provide evidence of a stable living residence in the last 2 months, have reasonable transportation to the study site, and have no plans to move within the next 3 months or unresolved legal problems

Exclusion Criteria:

• Any significant current medical conditions that would contraindicate smoking

• Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse

• Positive test results at intake appointment on urine drug screen for illicit drugs

• Past 30 days use of any psychoactive drugs including anxiolytics and antidepressants

• Women who are pregnant or nursing

• Suicidal, homicidal or evidence of current mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders

• Meeting DSM-IV criteria for current attention deficit hyperactivity disorder (ADHD)

• Individuals who are currently taking medications known to be effective for smoking cessation or are regular users of other tobacco products in the past 30 days

• Only one member per household can participate in the study

• Specific exclusions for administration of guanfacine not already specified include:

• EKG evidence at baseline screening for any clinically significant conduction abnormalities or arrhythmias

• Known intolerance for guanfacine or any alpha blocker

• History of fainting, syncopal attacks

• Heart failure or myocardial infarction

• Impaired liver (as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT) >3x normal)

• Renal function (as indicated by estimated creatinine clearance <60cc/min)

• Treatment with any antihypertensive drug or any alpha-adrenergic blocker

• Use of any central nervous system depressant (e.g., phenothiazines, barbiturates, benzodiazepines)

• Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole) or inducers (e.g., rifampin), or consumption of grapefruit juice

• Subjects may not have donated blood in the past 8 weeks or have been involved in other investigational studies that involve substantial blood draws or medications unknown to us

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale Center for Clinical Investigations, Yale University	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Sherry A McKee, PhD, Yale University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 7, 2021

More Information

Publications

None provided.

• Responsible Party: Sherry McKee, Professor of Psychiatry, Yale University
• ClinicalTrials.gov Identifier: NCT02051309
• Other Study ID Numbers: 1110009133_B; R01DA035001
• First Posted: Jan 31, 2014
• Last Update Posted: Dec 29, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sherry McKee, Professor of Psychiatry, Yale University: Smokers; Quit Smoking; Treatment; Guanfacine
• Additional relevant MeSH terms: Guanfacine

Study Results

Participant Flow

Arm/Group Title	Guanfacine 6mg/Day ER	Placebo
Arm/Group Description	Guanfacine 6mg/day extended release Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication.	Placebo matching capsule Placebo
Period Title: Overall Study
STARTED	58	63
COMPLETED	26	35
NOT COMPLETED	32	28

Baseline Characteristics

Arm/Group Title	Guanfacine 6mg/Day ER	Placebo	Total
Arm/Group Description	Guanfacine 6mg/day extended release Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication.	Placebo matching capsule Placebo	Total of all reporting groups
Overall Participants	58	63	121
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.17 (11.70)	47.68 (11.42)	47.91 (11.55)
Sex: Female, Male (Count of Participants)
Female	30 51.7%	30 47.6%	60 49.6%
Male	28 48.3%	33 52.4%	61 50.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	13 22.4%	11 17.5%	24 19.8%
White	42 72.4%	46 73%	88 72.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 5.2%	6 9.5%	9 7.4%
Cigarettes per day (cigarettes per day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cigarettes per day]	18.21 (7.67)	18.32 (8.66)	18.26 (8.19)

Outcome Measures

1. Primary Outcome

Title	Rates of Prolonged Smoking Abstinence
Description	Prolonged smoking abstinence defined as no relapse in week 3 to week 8, in participants with available outcome data during weeks 3 to 8.
Time Frame	Week 3 to week 8 during 8-week treatment phase

Outcome Measure Data

Analysis Population Description

Participants with available outcome data during weeks 3 to 8.

Arm/Group Title	Guanfacine 6mg/Day ER	Placebo
Arm/Group Description	Guanfacine 6mg/day extended release Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication.	Placebo matching capsule Placebo
Measure Participants	31	40
Count of Participants [Participants]	11 19%	7 11.1%

Adverse Events

Time Frame	During 8-week treatment period.
Arm/Group Title	Guanfacine 6mg/Day ER		Placebo
Arm/Group Description	Guanfacine 6mg/day extended release Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication.		Placebo matching capsule Placebo
All Cause Mortality
	Guanfacine 6mg/Day ER		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/63 (0%)
Serious Adverse Events
	Guanfacine 6mg/Day ER		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	Guanfacine 6mg/Day ER		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/63 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.