Treating Nicotine Addictio

Phase 4

• Conditions: NICOTINE ADDICTION; NICOTINE ADDICTIO

• Registration Number: PACTR201904758098529
• Lead Sponsor: Dalia Abdellateif Abdelghany

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-12
• Results First Posted: 2019-09-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess smoking status either (success to stop smoking, failure to stop smoking, lapse or relapse) at third months from starting treatment.

Secondary Outcome Measures

Name	Time	Method
Assess smoking status either (success to stop smoking, failure to stop smoking, lapse or relapse) at six months from starting treatment.