Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201904758098529 Date of Approval: 02/04/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Treating Nicotine Addiction
Official scientific title Efficacy of Nicotine Replacement Therapy, Bupropion and Both for Treating Nicotine Addiction
Brief summary describing the background and objectives of the trial Background: Previous researches on smoking in Egypt had focused mainly on providing prevalence data, motives for smoking, sociodemographic Factors and environmental tobacco smoke exposure. Most of studies about the efficacy of smoking cessation medication and their side effects were conducted in developed countries on participants who differ from Arab population in culture, beliefs, customs and genetics. Methods: Prospective interventional randomized trial was conducted on convenient sample of (100) smokers at smoking cessation clinic, Mansoura University Hospitals. Participants were allocated into 4 groups (NRT, bupropion, NRT plus bupropion and placebo). Counseling was offered to all participants. Outcomes: Assess smoking status either (success to stop smoking, failure to stop smoking, lapse or relapse) at third and sixth month from starting treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied NICOTINE ADDICTION
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2015
Actual trial start date 01/04/2015
Anticipated date of last follow up 31/07/2017
Actual Last follow-up date 31/07/2017
Anticipated target sample size (number of participants) 266
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL not applicable
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1 Nicotine replacement therapy Nicorette Gum 2mg & 4mg: 2 mg gum (for smokers who smoked < 20 cigarettes per day) and 4 mg gum (for smokers who smoked > 20 cigarettes per day) 3 months as primary outcome and 6 months as a secondary outcome Smokers in this group received nicotine replacement therapy alone in the form of nicotine gum. Nicotine replacement therapy manufactured by: (1) Johnson & Johnson, 1 Johnson & Johnson Plaza, New Brunswick, NJ 08933. (2) GlaxoSmithKline Consumer Healthcare LP, 1000 GSK Drive, Moon Township, PA 15108. Dose: 2 mg gum (for smokers who smoked < 20 cigarettes per day) and 4 mg gum (for smokers who smoked > 20 cigarettes per day). - Counseling session was offered to all participants in the first visit lasting for about 10-15 minutes. - Personalized counseling sessions were offered in each follow up visit. In these sessions, we targeting relapse causes in previous trials and motivation to quit smoking at present trial. • Participants were encouraged to do a follow up visit per week throughout period of treatment ( either face to face visit or through telephone call) • Face to face visits were done at (3)month and at (6) month 25
Experimental Group Group 2 Bupropion Bupropion hydrochloride (Wellbutrine 150 mg SR) Smoker started with 150 mg for six days, increased to 150 mg twice daily on day seven 3 months as primary outcome and 6 months as a secondary outcome Smokers in this group received bupropion alone. Bupropion hydrochloride manufactured by: GlaxoSmithKline plc. Registered in England and Wales No.3888792. Registered office: 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom. - Counseling session was offered to all participants in the first visit lasting for about 10-15 minutes. - Personalized counseling sessions were offered in each follow up visit. In these sessions, we targeting relapse causes in previous trials and motivation to quit smoking at present trial. • Participants were encouraged to do a follow up visit per week throughout period of treatment ( either face to face visit or through telephone call) • Face to face visits were done at (3) month and at (6) month 25
Experimental Group Group 3 NRT and Bupropion Nicorette Gum 2mg & 4mg: 2 mg gum (for smokers who smoked < 20 cigarettes per day) and 4 mg gum (for smokers who smoked > 20 cigarettes per day). Bupropion hydrochloride (Wellbutrine 150 mg SR): Smoker started with 150 mg for six days, increased to 150 mg twice daily on day seven 3 months as primary outcome and 6 months as a secondary outcome Smokers at this group received combination of nicotine gum plus Bupropion Nicotine replacement therapy manufactured by: (1) Johnson & Johnson, 1 Johnson & Johnson Plaza, New Brunswick, NJ 08933. (2) GlaxoSmithKline Consumer Healthcare LP, 1000 GSK Drive, Moon Township, PA 15108. Bupropion hydrochloride manufactured by: GlaxoSmithKline plc. Registered in England and Wales No.3888792. Registered office: 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom. - Counseling session was offered to all participants in the first visit lasting for about 10-15 minutes. - Personalized counseling sessions were offered in each follow up visit. In these sessions, we targeting relapse causes in previous trials and motivation to quit smoking at present trial. • Participants were encouraged to do a follow up visit per week throughout period of treatment ( either face to face visit or through telephone call) • Face to face visits were done at (3) month and at (6) month 25
Control Group Group 4 Placebo tablet of 435 mg of the mixture (Microcrystalline cellulose, hydroxypropyl methylcellulose and magnesium stearate, Talc and lactose) 1 tablet twice daily. 3 months as primary outcome and 6 months as a secondary outcome Smokers at this group received placebo. Placebo tablets were prepared by direct compression. The respective powders [microcrystalline cellulose and hydroxypropyl methylcellulose] were blended thoroughly in a rotating bottle for 10 min. After that, lactose was added instead of the drug (bupropion hydrochloride). Then, talc and magnesium stearate were added and mixing was continued for additional 5 min. Finally, 435 mg of the mixture were weighed and fed into the die of a single punch tableting press (Type EKO, Erweka-Apparatebau, GmbH, Germany), equipped with flat-faced punches (10 mm). The compression pressure was adjusted to give tablet hardness a value between 6 and 7 kg. - Counseling session was offered to all participants in the first visit lasting for about 10-15 minutes. - Personalized counseling sessions were offered in each follow up visit. In these sessions, we targeting relapse causes in previous trials and motivation to quit smoking at present trial. • Participants were encouraged to do a follow up visit per week throughout period of treatment ( either face to face visit or through telephone call) • Face to face visits were done at (3) month and at (6) month 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Apparently healthy cigarette smokers 2- Smokers who were motivated to quit and were willing to attend scheduled study visits. 3- Smokers aged 18 years or over. 4- Consent had been obtained. 5- Smokers with no contraindication to treatment with bupropion or nicotine gum. 1- Smokers who were not sufficiently motivated to quit. 2- Smokers under the age of 18 years. 3- Pregnant or nursing mothers. 4- Hypersensitivity to bupropion or nicotine gum. 5- Smokers with diabetes or hypertension. 6- History of cardiac or chest diseases. 7- History of hepatic or renal impairment. 8- History of epilepsy or head trauma. 9- Risk factor for seizures. 10- Evidence of CNS tumors 11- Smokers with a current/previous diagnosis of bulimia/anorexia nervosa. 12- Drug or alcohol abusers. 13- History of bi-polar mode or psychiatric disorders. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/03/2015 Medical Research Ethics Committee. Mansoura University
Ethics Committee Address
Street address City Postal code Country
AlGamaa Distrcit. AlGomhoria St. Faculty of Medicine building Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assess smoking status either (success to stop smoking, failure to stop smoking, lapse or relapse) at third months from starting treatment. 3 months from starting treatment
Secondary Outcome Assess smoking status either (success to stop smoking, failure to stop smoking, lapse or relapse) at six months from starting treatment. 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Smoking cessation clinic Mansoura University Hospitals Gihan st. Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dalia Abdellateif Abdelghany Suiz Canal St. NO 155 Mansoura 35519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dalia Abdellateif Abdelghany Suiz canal St. No 155 Mansoura 35519 Egypt Individual
Secondary Sponsor pharmaceutics Department. Faculty of Pharmacy Algamaa Distrct, Faculty of pharmacy building, Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dalia Abdellateif Abdelghany Manosura University, Chest medicine Department, AlGomhoria St. Mansoura 35516 Egypt
Tamer Ali Elhadedy Chest Medicine Department, Faculty of Medicine, Mansoura University, AlGomhoria St. Mansoura 35516 Egypt
Nesrien Mohammad Shalabi Chest Medicine Department, Faculty of Medicine, Mansoura University, Algomhoria St. Mansoura 35516 Egypt
Amina Mahmoud Abdelmaksoud Chest Medicine Department, Faculty of Medicine, Mansoura University, AlGomhoria St. Mansoura 35516 Egypt
Wafaa Abd ElHakim ElBahaey Psychiatry Department, Faculty of Medicine, Mansoura University, Mansoura, Gihan St. Manosura 35516 Egypt
Marwa Salah ElDahan Pharmaceutics Department, Faculty of Pharmacy, Mansoura University, Gihan St. Manosura 35516 Egypt
Nesrine Saad Farrag Community Medicine Department, Faculty of Medicine, Mansoura University, Algomhoria St. Manosura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dalia Abdelghany dalia0000dalia@gmail.com 00201006602396 Suiz Canal St. No 155
City Postal code Country Position/Affiliation
Mansoura 35519 Egypt Lecturer of Chest Medicine. Mansoura University
Role Name Email Phone Street address
Public Enquiries Nesrine Farrag nesrine.farrag@gmail.com 002001019992083 Dr. Nagy abdelRazik st. No 22
City Postal code Country Position/Affiliation
Manosura 11033 Egypt lecturer of public health. Manosura University
Role Name Email Phone Street address
Scientific Enquiries Dalia Abdelghany dalia0000dalia@gmail.com 00201006602396 Suiz Canal St. No 155
City Postal code Country Position/Affiliation
Mansoura 35519 Ecuador Lecturer of chest medicine. Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes SPSS file of the data of all participants Study Protocol already available on Mendely datasets Farrag, Nesrine (2019), “Efficacy of nicotine replacement therapy, bupropion, and both for treating nicotine addiction”, Mendeley Data, v1 http://dx.doi.org/10.17632/7yns77mnsh.1 will be publicly available once the paper published
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://dx.doi.org/10.17632/7yns77mnsh.1 Yes Summary results The study included 25 participants in 4 group. There were no significant differences between the studied groups with regard to age and marital status. There was significant difference between groups with regard to Smoking index and Fagerstorm scale, but not for Ex CO, or pulmonary function tests. Nearly, half of participants have tried quitting smoking with very small percentage who used medications for these trials. Peer pressure (34%) was the most commonly cited cause of relapse in previous cessation trials followed by Withdrawal symptoms (30%), urgency (16.3), and social troubles (9.3%). Health concerns were the most commonly reported motivation to quit smoking. There were no significant differences between any of the groups with regard to Ex CO measurements at 3 nor 6 months. (not presented in table). There are no significant differences in success rates between the 4 groups at 3 nor 6 Months of starting treatment. There were no serious adverse events in the studied groups. Urgency was more prevalent among participants in Placebo group compared to other groups, with significant difference from NRT group(p=0.001). Similarly, Headache was only reported by participants in placebo group with significant difference from all other groups (p=0.01). 02/04/2019 01/09/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks http://dx.doi.org/10.17632/7yns77mnsh.1
Changes to trial information