Nutritional supplements and withdrawal symptoms in smoking cessation.

INTERVENTION: Double blind randomized controlled trial (RCT) comparing a mineral and vitamin supplement Daily Essential Nutrients (DEN) with a placebo. The intervention consists of a micronutrient formula (DEN) containing 41 ingredients: The doses of each ingredient of one capsule are: Vitamin A (as retinyl palmitate) 384 IU Vitamin C (as ascorbic acid) 40 mg Vitamin D (as cholecalciferol) 200 IU Vitamin E (as d‐alpha tocopheryl succinate) 24 IU Vitamin K (as phylloquinone) 6 mcg Vitamin K (as menaquinone‐7) 2 mcg Thiamin (as thiamin mononitrate) 4 mg Riboflavin 1.2 mg Niacin (as niacinamide) 6 mg Vitamin B6 (as pyridoxine hydrochloride) 4.6667 mg Folate (as folic acid) 50 mcg Folate (as L‐methylfolate calcium) 50 mcg Vitamin B12 (as methylcobalamin) 60 mcg Biotin 72 mcg Pantothenic acid (as d‐calcium pantothenate) 2 mg Calcium (as chelate) 88 mg Iron (as chelate) 0.916 mg Phosphorus (as chelate) 56 mg Iodine (as chelate) 13.6 mcg Magnesium (as chelate) 40 mg Zinc (as chelate) 3.2 mg Selenium (as chelate) 13.6 mcg Copper (as chelate) 0.48 mg Manganese (as chelate) 0.64 mg Chromium (as chelate) 41.6 mcg Molybdenum (as chelate) 9.6 mcg Potassium (as chelate) 16 mg Choline bitartrate 36 mg Alpha‐lipoic acid 33.333 mg Shilajit 12.5 mg Inositol 12 mg Acetylcarnitine (as acetyl‐L‐carnitine hydrochloride) 4 mg Grape seed extract 3 mg Ginkgo biloba leaf extract 2.4 mg Methionine (as L‐methionine hydrochloride) 2 mg Cysteine (as N‐acetyl‐L‐cysteine) 2 mg Germanium sesquioxide (as chelate) 1.38 mg Boron (as chelate) 0.16 mg Vanadium (as chelate) 0.0796 mg Lithium orotate (as chelate) 0.0667 mg Nickel (as chelate) 0.002 mg Other ingredients: Cellulose 49.122 mg Glycine 45 mg Citric acid 26.814 mg Magnesium stearate 24 mg Silicon dioxide 20 mg Baseline phase: Participants complete a baseline phase of 1,2, or 3 weeks. During the baseline phase cigarette consumption, mood and withdrawal symptoms are monitored daily. Capsule intervention phase: Participants swallow up to a target dose of 12 capsules of DEN or placebo a day divided into three doses of 4 pills each dose for a total of 16 weeks. Participants will begin by taking one capsule, 3 times each day, increasing the dose by three capsules every two days up to a target dose of 12 capsules per day: 4 taken at 3 different intervals. Compliance will be monitored with diaries and pill counts. Cigarette consumption, mood and withdrawal will be monitored during week 1 and 4 of this phase. Smoking Cessation phase: CONDITION: Tobacco addiction PRIMARY OUTCOME: Minnesota Nicotine Withdrawal Scale ‐ Short 8 item and long 18 item version SECONDARY OUTCOME: Anxiety Sensitivity Index. Fagerstrom Test for Nicotine Dependence Capsule compliance assessed by counting any left over capsules and self report diaries. Cigarette consumption assessed with self report diaries. Depression Anxiety Sensitivity Index‐21, Mood and Physical symptoms scale. Quit Rate assessed with self‐report diaries that ask about cigarette consumption. Quitline use assessed with self report diaries. Relapse rate assessed with self report diaries. After 4 weeks of taking the capsules participants begin a smoking cessation intervention following Quitline New Zealand's five step program (with the exclusion of step 4 nicotine patches and gum). Standard Quitline care coincides with the continuing consumption of the capsules. Participants monitor mood and withdrawal symptoms for the first month after quit date, then for the last week of the consecutive 2 months using a diary that they carry with them. Every 2 weeks participants complete withdrawal, dependence, depression, anxiety sensitivity and a side effects questionnaire. Participants come in to the laboratory every 4 weeks for 3 months to receive more capsules, complete questionnaires and talk about smoking cessation. Participants take the capsules for 3 months during the smoking cessation phase. Adherence to protocol during the smoking cessation phase is monitored with self report diaries, and pill counts. All participants will then be followed up 3 months after the trial. INCLUSION CRITERIA: 1) 18 years old or over 2) Meet a 'current smoking' criteria of smoking at least 2 cigarettes a day for the past year. 3) No serious medical conditions requiring treatment during the trial period. 4) Are not on psychoactive medication. Participants must be medication free for at least 4 weeks prior to beginning the trial.