Modeling Stress-precipitated Smoking Behavior for Medication Development

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00773357
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), Office of Research on Women's Health (ORWH) (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 154
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to examine whether guanfacine will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking daily smokers.

Condition or Disease	Intervention/Treatment	Phase
Smoking	Drug: guanfacine; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Modeling Stress-precipitated Smoking Behavior for Medication Development
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Jul 31, 2021
• Actual Study Completion Date: Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guanfacine guanfacine 3mg/day	Drug: guanfacine; 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.; Other Names: Tenex
Placebo Comparator: Placebo placebo control	Drug: placebo; placebo

Outcome Measures

Primary Outcome Measures

1. Latency to Initiate Ad-lib Smoking Session [50 minutes]

   latency to initiate smoking (in minutes) during a 50-minute period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ages 18-60

• able to read and write in English

• smokers

Exclusion Criteria:

• any significant current medical conditions that would contraindicate smoking

• current Diagnostic and Statistical Manual IV (DSM-IV) abuse or dependence of other substances, other than nicotine (or caffeine) dependence

• positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines

• women who are pregnant or nursing

• suicidal, homicidal or evidence of severe mental illness

• participants prescribed any psychotropic drug in the 30 days prior to study enrollment

• blood donation within the past 6 weeks

• participants who have engaged in a quit attempt in the past 3 months

• specific exclusions for administration of guanfacine not already specified include: Hypotensive individuals with sitting blood pressure below 90/50 mmHG; EKG evidence at baseline screening of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) >450 msec for men and QTc>470 msec for women; known intolerance for guanfacine

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)
• Office of Research on Women's Health (ORWH)
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 31, 2022

More Information

Publications

None provided.

• Responsible Party: Sherry McKee, Professor of Psychiatry, Yale University
• ClinicalTrials.gov Identifier: NCT00773357
• Other Study ID Numbers: 0808004163; RL1DA024857; P50DA033945; P01AA027473; U54AA027989
• First Posted: Oct 16, 2008
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Keywords provided by Sherry McKee, Professor of Psychiatry, Yale University: smoking lapse behavior; guanfacine
• Additional relevant MeSH terms: Guanfacine

Study Results

Participant Flow

Arm/Group Title	Guanfacine	Placebo
Arm/Group Description	guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.	placebo control placebo: placebo
Period Title: Overall Study
STARTED	50	50
COMPLETED	50	50
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Guanfacine	Placebo	Total
Arm/Group Description	guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.	placebo control placebo: placebo	Total of all reporting groups
Overall Participants	50	50	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.36 (10.05)	36.92 (11.73)	36.14 (10.89)
Sex: Female, Male (Count of Participants)
Female	23 46%	22 44%	45 45%
Male	27 54%	28 56%	55 55%
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 26%	18 36%	31 31%
White	32 64%	28 56%	60 60%
More than one race	5 10%	4 8%	9 9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	50 100%	50 100%	100 100%
Cigarettes per day (cigarettes per day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cigarettes per day]	15.44 (7.58)	15.12 (8.11)	15.28 (7.845)

Outcome Measures

1. Primary Outcome

Title	Latency to Initiate Ad-lib Smoking Session
Description	latency to initiate smoking (in minutes) during a 50-minute period.
Time Frame	50 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Guanfacine	Placebo
Arm/Group Description	guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.	placebo control placebo: placebo
Measure Participants	50	50
Mean (Standard Error) [minutes]	31.55 (5.30)	30.31 (5.44)

Adverse Events

Time Frame	Titration period of 21 days
Arm/Group Title	Guanfacine		Placebo
Arm/Group Description	guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.		placebo control placebo: placebo
All Cause Mortality
	Guanfacine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Serious Adverse Events
	Guanfacine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Guanfacine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/50 (70%)		12/50 (24%)
Gastrointestinal disorders
Constipation	10/50 (20%)		6/50 (12%)
General disorders
dry mouth	35/50 (70%)		12/50 (24%)
Drowsiness	19/50 (38%)		9/50 (18%)
Fatigue	18/50 (36%)		2/50 (4%)
Nervous system disorders
Dizziness	5/50 (10%)		4/50 (8%)
Headache	15/50 (30%)		10/50 (20%)
Reproductive system and breast disorders
Impotence	1/50 (2%)		1/50 (2%)

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.