Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study

This study has been completed.

Sponsor:

Collaborator:

Shire Development LLC

Information provided by (Responsible Party):

Duke University

ClinicalTrials.gov Identifier:

NCT00736255

First received: August 13, 2008

Last updated: August 7, 2012

Last verified: June 2012

History of Changes

Results First Received: August 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Attention Deficit Hyperactivity Disorder Nicotine Dependence
Interventions:	Drug: Lis-dexamphetamine (LDX; Vyvanse) and Transdermal Nicotine Patch Drug: Placebo and transdermal nicotine patch

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment ended in March 2011 at the Duke.A total of 59 subjects were screened. 24 did not pass screening while 35 were eligible. Of the 35 screen passers, 32 were randomized to receive either LDX or placebo, 3 were withdrawn prior to randomization. Of the 32 randomized, 17 received LDX and 15 received placebo. 14 completed on each arm.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 24 screen fails. Reason for Screen Fails include:Did not complete screening - 2,Carbon monoxide too low - 3,Positive Urine drug screen - 3,Physical health reasons - 5,Psychiatric comorbidity - 11

Reporting Groups

	Description
LDX and NRT	• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
NRT and Placebo	The second group will receive matching placebo and NRT after the quit date.

Participant Flow: Overall Study

	LDX and NRT	NRT and Placebo
STARTED	17	15
COMPLETED	14	14
NOT COMPLETED	3	1
Adverse Event	1	0
Physician Decision	1	0
Non-compliance	1	1

Baseline Characteristics

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Reporting Groups

	Description
LDX and NRT	• The first group will receive LDX/SPD489 titrated up to 70 mg qd for 4 weeks after the identified quit date. Subjects will continue to receive NRT 21 mg at week 1 post quit date, then 14mg at week 2 post quit date and 7 at weeks 3 and 4 post quit date.
NRT and Placebo	The second group will receive matching placebo and NRT after the quit date.
Total	Total of all reporting groups

Baseline Measures

	LDX and NRT	NRT and Placebo	Total
Number of Participants [units: participants]	17	15	32
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	17	15	32
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	29.6 ± 8.4	33.5 ± 9.1	31 ± 8.5
Gender [units: participants]
Female	6	9	15
Male	11	6	17
Region of Enrollment [units: participants]
United States	17	15	32

Outcome Measures

1. Primary:

The Number of Subjects in Each Treatment Group Exhibiting Sustained, 4-week Smoking Abstinence, Defined as CO Levels < 4 Ppm for Each Post-quit Study Visit. [ Time Frame: 4 weeks ]

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2. Secondary:

Smoking Rates. Cognitive Function. ADHD Rating Scales at Pre and Post Quit Period [ Time Frame: 6 weeks ]

Results not yet posted. Anticipated Posting Date: 10/2011 Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of the study: 1. Our sample size was quite small and this can realistically only be considered a pilot trial. 2.We did not collect systematic follow-up data on our sample after the end of treatment.3.the duration of our trial was short.

Results Point of Contact:

Name/Title: Scott Kollins, PhD
Organization: DukeUMC
phone: 9196810014
e-mail: kolli001@mc.duke.edu

No publications provided

Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00736255 History of Changes
Other Study ID Numbers:	00001248, SPD489-607
Study First Received:	August 13, 2008
Results First Received:	August 17, 2011
Last Updated:	August 7, 2012
Health Authority:	United States: Food and Drug Administration

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