Condition category
Not Applicable
Date applied
03/05/2006
Date assigned
05/06/2006
Last edited
19/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elbert D Glover

ORCID ID

Contact details

University of Maryland
2387 HHP Building
College Park
Maryland
20742
United States of America
+1 301 405 2467
eglover1@umd.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

To determine the efficacy and safety of nicotine transdermal therapy co-administered with the nicotine antagonist, mecamylamine; as compared to a nicotine transdermal patch alone (21 mg nicotine + 6 mg mecamylamine, 21 mg nicotine + 3 mg mecamylamine, and 21 mg nicotine + 0 mg mecamylamine).

Ethics approval

Approved by the West Virginia University's Institutional Review Board in 1997, reference number: HS13781

Study design

Multicenter (n=4), double-blind, randomized, parallel group, repeat dose study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cigarette smoking

Intervention

Treatment was administered for the first six weeks of the 8-week study. Patients were instructed to continue smoking for the first two weeks of treatment.
Patients were randomised into one of the following groups:
1. 21 mg nicotine + 6 mg mecamylamine
2. 21 mg nicotine + 3 mg mecamylamine
3. 21 mg nicotine + 0 mg mecamylamine

Intervention type

Drug

Phase

Not Specified

Drug names

Mecamylamine, nicotine

Primary outcome measures

Analysis of the four-week continuous abstinence for the intent-to-treat population using the slip definition, which allows smoking in the first two weeks after the quit date.

Secondary outcome measures

Analysis of the four-week continuous abstinence for the intent-to-treat population using the strict definition (no smoking after the quit date).

Overall trial start date

01/01/1997

Overall trial end date

31/12/1998

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males or females motivated to quit smoking between the ages of 18 and 70 years
2. Smoked at least 20 cigarettes a day for three years or more (smoking confirmed via expired CO level >10 ppm).
All subjects had normal blood pressure and heart rate, weighed more than 100 pounds and typically no more than 130% of their ideal body weight, and expressed willingness to quit smoking on the specified target quit date (TQD). They were not currently using smokeless tobacco or other nicotine products. A detailed medical history, routine physical examination, laboratory tests and electrocardiogram (ECG) confirmed that subjects were in general good health. All women had a negative pregnancy test and agreed to use a medically accurate contraceptive method.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

375

Participant exclusion criteria

Participants were excluded if they had a history of significant hepatic, renal, endocrine, cardiac, psychiatric, gastrointestinal, pulmonary, or metabolic disorder including hyperthyroidism, pheochromocytoma, diabetes, severe coronary insufficiency, recent myocardial infarction (within 90 days), glaucoma, cerebrovascular disease, stroke, chronic renal failure, prostatic hypertrophy, prostatic disease, bladder neck obstruction, urine retention, urethral stricture, a history of atopic or eczematous dermatitis, psoriasis, or altered skin condition at patch application site.

Recruitment start date

01/01/1997

Recruitment end date

31/12/1998

Locations

Countries of recruitment

United States of America

Trial participating centre

University of Maryland
Maryland
20742
United States of America

Sponsor information

Organisation

Elan Corp (USA)

Sponsor details

Medical Affairs
7475 Lush Boulevard
San Diego
92121
United States of America
+1 858 457 2555
mcdermottg@iconus.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Elan Corp (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17506156

Publication citations

  1. Results

    Glover ED, Laflin MT, Schuh KJ, Schuh LM, Nides M, Christen AG, Glover PN, Strnad JV, A randomized, controlled trial to assess the efficacy and safety of a transdermal delivery system of nicotine/mecamylamine in cigarette smokers., Addiction, 2007, 102, 5, 795-802.

Additional files

Editorial Notes