NCT02046551

Brief Summary

The purpose of this study is to evaluate atomoxetine's effects on the rewarding and reinforcing effects of nicotine in a controlled human laboratory study with 24 otherwise healthy nicotine dependent subjects. It is hypothesized that atomoxetine will attenuate the negative effects of nicotine.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

January 23, 2014

Last Update Submit

May 19, 2017

Conditions

Nicotine Dependence

Keywords

nicotinesmokingatomoxetinestress

Outcome Measures

Primary Outcomes (2)

  • Nicotine Effects Questionnaire

    Subjects will rate 6 items that are related to nicotine effect on a 100 mm scale, "not at all" to "extremely." The items are feeling the drug strength, feel "good" drug effects, feel "bad" drug effects, feel jittery, feel stimulated, and head rush. This instrument is an abbreviated version of a visual analog scale (VAS) and allows rapid detection of nicotine effects.

    Day 5

  • Nicotine Effects Questionnaire

    Subjects will rate 6 items that are related to nicotine effect on a 100 mm scale, "not at all" to "extremely." The items are feeling the drug strength, feel "good" drug effects, feel "bad" drug effects, feel jittery, feel stimulated, and head rush. This instrument is an abbreviated version of a visual analog scale (VAS) and allows rapid detection of nicotine effects.

    Day 17

Secondary Outcomes (10)

  • Center for Epidemiologic Studies Depression (CES-D) scale

    Day 5

  • Positive and Negative Affect Schedule (PANAS )

    Day 5

  • The Profile of Mood States (POMS)

    Day 5

  • Center for Epidemiologic Studies Depression (CES-D) scale

    Day 17

  • Positive and Negative Affect Schedule (PANAS )

    Day 17

  • +5 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Atomoxetine

EXPERIMENTAL

atomoxetine (40 mg/day)

Drug: Atomoxetine

Interventions

AtomoxetineDRUG
Also known as: Strattera
Atomoxetine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female and male smokers, not treatment seeking, aged 18 to 55 years;
  • history of smoking daily for the past 12 months, at least 5 cigarettes daily;
  • CO level \> 10ppm;
  • for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

You may not qualify if:

  • history of major medical illnesses including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment, coronary artery disease, cardiac rhythm disturbances or other medical conditions that the study physician deems contraindicated for the subject to be in the study;
  • regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
  • recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year. We will make an exception for the following Axis I diagnoses: nicotine dependence and alcohol or other drug dependence (i.e., cocaine, opioid) as long as they are not meeting abuse or dependence criteria within the past 3 months for alcohol or drug use;
  • use of drugs that slow heart rate (eg, beta-blockers), which may increase the risk of bradycardia and AV block, or NSAIDs, which may increase potential for developing ulcers/active or occult gastrointestinal bleeding;
  • known allergy to atomoxetine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Haven Veterans Affairs

West Haven, Connecticut, 06515, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmoking

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Albert Arias, MD

    Yale University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 27, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 22, 2017

Record last verified: 2017-05

Locations

US(1)