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A 2x2 phase II randomized controlled trial to investigate the efficacy of NRT plus St John's wort versus NRT plus placebo in smoking cessation and to examine the efficacy of chromium nicotinate versus placebo in preventing weight gain while stopping smoking. - SJW and chromium in smoking cessation

A 2x2 phase II randomized controlled trial to investigate the efficacy of NRT plus St John's wort versus NRT plus placebo in smoking cessation and to examine the efficacy of chromium nicotinate versus placebo in preventing weight gain while stopping smoking. - SJW and chromium in smoking cessation

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000662-39-GB
Enrollment
144
Registered
2005-08-09
Start date
2005-10-04
Completion date
Unknown
Last updated
2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stopping smoking.

Interventions

Trade Name: Jarsin Pharmaceutical Form: Capsule, hard INN or Proposed INN: st john's wort extract Concentration unit: mg milligram(s) Co

Sponsors

Oxford Brookes University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All smokers 18 years or over that want to stop smoking and that have smoked at least 10 cigarettes per day for the past year. Clinically suitable to take NRT, SJW, and Cr. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Pregnant and breast feeding women, or women that are planning pregnancy while they would be scheduled to be on medication 2) Severe liver impairment 3) Current depression or recent moderate-severe depression (checked using the two screening questions recommended by NICE and by current use of antidepressant medication or past use during the past two years. 4) People taking some antidepressants, antipsychotics, immunosupressants, digoxin, the pill, methadone (see exclusion list)

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate whether or not either of the two treatments either in combination or alone are effective for helping people to stop smoking. To see if either of these treatments reduce normal weight gain following smoking abstinence.;Secondary Objective: Changes in the early morning rise of salivary cortisol. Changes in the anxiety scores and urge to smoke as measured by questionaire. Changes in plasma levels of prolactin, NEFFAs, triglycerides, free tryptophan and LNAAs. ;Primary end point(s): Seven day abstinence from smoking confirmed by exhaled CO measured 28 days after quitting. Change in mean weight.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026