Compositions comprising cytisine in the treatment and/or prevention of addiction in subjects in need thereof

Abstract

Methods of treatment of addiction and/or dependence, methods of promoting cessation of various addictions, such as smoking and/or vaping, and methods of promoting a reduction in various addictions, such as smoking and/or vaping, uses of cytisine as an addiction cessation treatment, and dosage regimens for the foregoing are provided.

I/we claim: 
     
         1 . A method of treating a nicotine dependence, treating a nicotine addiction, promoting cessation of smoking and/or vaping, and/or promoting a reduction in smoking and/or vaping in a subject in need thereof, the method comprising administering cytisine provided in a unit dose of 3.0 mg, 1.5 mg, or 1.0 mg of cytisine three times daily to the subject. 
     
     
         2 . The method of  claim 1 , wherein the subject experiences no adverse events after receiving the cytisine treatment. 
     
     
         3 . The method of  claim 2 , wherein the adverse event is selected from the group consisting of an upper respiratory tract infection (URTI), abnormal dreams, nausea, insomnia, headache, fatigue, and constipation. 
     
     
         4 . The method of  claim 3 , wherein the subject experiences no nausea after receiving the cytisine treatment. 
     
     
         5 . The method of  claim 1 , wherein cytisine is administered for about 6 weeks or for about 12 weeks. 
     
     
         6 . The method of  claim 1 , wherein the unit dose of cytisine comprises (a) two tablets, each tablet either containing 1.5 mg or 3.0 mg of cytisine, (b) a single tablet either containing 1.5 mg or 3.0 mg of cytisine, or (c) three tablets, each tablet containing 1.0 mg of cytisine. 
     
     
         7 . The method of  claim 1 , wherein the subject is a refractory patient who has failed treatment with one or more nicotine addiction or smoking cessation treatments. 
     
     
         8 . The method of  claim 7 , wherein the nicotine addiction or smoking cessation treatments are selected from nicotine replacement therapy (NRT), administration of bupropion, administration of varenicline, electronic cigarettes, vaping, and a combination thereof. 
     
     
         9 . The method of  claim 1 , wherein the subject (a) smoked ten or more cigarettes per day prior to the administration of cytisine, (b) has expired air CO concentration of about 10 ppm or greater prior to the administration of cytisine, or (c) a combination of (a) and (b). 
     
     
         10 . The method of  claim 1 , further comprising providing behavioral support to the subject. 
     
     
         11 . A method of treating of nicotine addiction in a subject in need thereof, the method comprising administering cytisine to the subject, wherein the subject is a refractory patient who has failed treatment with one or more nicotine addiction treatments. 
     
     
         12 . The method of  claim 11 , wherein the nicotine addiction treatments comprise NRT, administration of bupropion, administration of varenicline, electronic cigarettes, vaping, or a combination thereof. 
     
     
         13 . The method of  claim 10 , wherein cytisine is provided in a unit dose of about 1.0 mg to about 6.0 mg of cytisine three to six times daily to a subject in need thereof. 
     
     
         14 . The method of  claim 10 , wherein cytisine is provided in a unit dose of 3.0 mg of cytisine three times daily to a subject in need thereof. 
     
     
         15 . The method of  claim 13 , wherein the unit dose of cytisine comprises (a) two tablets, each tablet either containing 1.5 mg or 3.0 mg of cytisine, (b) a single tablet either containing 1.5 mg or 3.0 mg of cytisine, or (c) three tablets, each tablet containing 1.0 mg of cytisine. 
     
     
         16 . The method of  claim 15 , wherein cytisine is administered for about 6 weeks or for about 12 weeks. 
     
     
         17 . The method of  claim 10 , wherein the subject experiences no adverse events after receiving the cytisine treatment. 
     
     
         18 . The method of  claim 17 , wherein the adverse event is selected from the group consisting of an URTI, abnormal dreams, nausea, insomnia, headache, fatigue, and constipation. 
     
     
         19 . The method of  claim 10 , wherein the subject (a) smoked ten or more cigarettes per day prior to the administration of cytisine, (b) has expired air CO concentration of about 10 ppm or greater prior to the administration of cytisine, or (c) a combination of (a) and (b). 
     
     
         20 . A method of preventing smoking and/or vaping relapse in a subject in need thereof, the method comprising administering cytisine provided in a unit dose of (a) two tablets, each tablet either containing 1.5 mg or 3.0 mg of cytisine, (b) a single tablet either containing 1.5 mg or 3.0 mg of cytisine, or (c) three tablets, each tablet containing 1.0 mg of cytisine, three times daily to the subject. 
     
     
         21 . The method of  claim 20 , wherein cytisine is administered for about 6 weeks or for about 12 weeks. 
     
     
         22 . The method of  claim 20 , wherein the subject experiences no adverse events after receiving the cytisine treatment. 
     
     
         23 . The method of  claim 22 , wherein the adverse event is selected from the group consisting of an URTI, abnormal dreams, nausea, insomnia, headache, fatigue, and constipation. 
     
     
         24 . The method of  claim 20 , wherein the subject (a) smoked ten or more cigarettes per day prior to the administration of cytisine, (b) has expired air CO concentration of about 10 ppm or greater prior to the administration of cytisine, or (c) a combination of (a) and (b). 
     
     
         25 . The method of  claim 20 , wherein the subject is a refractory patient who has failed treatment with one or more smoking cessation treatments. 
     
     
         26 . The method of  claim 25 , wherein the smoking cessation treatments comprise NRT, administration of bupropion, administration of varenicline, electronic cigarettes, vaping, or a combination thereof. 
     
     
         27 . A method of preventing smoking and/or vaping relapse in a subject in need thereof, the method comprising administering cytisine to the subject, wherein the subject is a refractory patient who has failed treatment with one or more smoking cessation treatments selected from the group consisting of NRT, administration of bupropion, administration of varenicline, electronic cigarettes, vaping. 
     
     
         28 . The method of  claim 27 , wherein the subject (a) smoked ten or more cigarettes per day prior to the administration of cytisine, (b) has expired air CO concentration of about 10 ppm or greater prior to the administration of cytisine, or (c) a combination of (a) and (b). 
     
     
         29 . The method of  claim 27 , wherein the unit dose of cytisine comprises (a) two tablets, each tablet either containing 1.5 mg or 3.0 mg of cytisine, (b) a single tablet either containing 1.5 mg or 3.0 mg of cytisine, or (c) three tablets, each tablet containing 1.0 mg of cytisine, and wherein cytisine is administered for about 6 weeks or for about 12 weeks. 
     
     
         30 . The method of  claim 27 , wherein the subject experiences no adverse events selected from the group consisting of an URTI, abnormal dreams, nausea, insomnia, headache, fatigue, and constipation after receiving the cytisine treatment.