Compositions and methods for prophylaxis and treatment of addictions
Inventors
Assignees
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Publication Number
US-11241420-B2
Publication Date
2022-02-08
Expiration Date
Abstract
The present invention relates to methods of treating or preventing addiction and relapse use of addictive agents, and treating or preventing addictive or compulsive behaviour and relapse practice of an addictive behaviour or compulsion, by administering a peroxisome proliferator-activated receptor gamma (PPARγ) agonist, alone or in combination with another therapeutic agent, such as, for example, an opioid receptor antagonist or an antidepressant, or an addictive agent, such as, for example, an opioid agonist. The present invention also includes pharmaceutical compositions for treating or preventing addiction or relapse that include a PPARγ agonist and one or more other therapeutic or addictive agents, as well as unit dosage forms of such pharmaceutical compositions, which contain a dosage effective in treating or preventing addiction or relapse. The methods and compositions of the invention are useful in the treatment or prevention of addiction to any agent, including alcohol, nicotine, marijuana, cocaine, and amphetamines, as well as compulsive and addictive behaviours, including pathological gambling and pathological overeating.
Core Innovation
The disclosed invention provides pharmaceutical compositions and unit dosage forms that combine an effective amount of nicotine with an effective amount of a peroxisome proliferator-activated receptor gamma (PPARγ) agonist that is a thiazolidinedione (TZD). The effective amount of the PPARγ agonist functions to prevent a subject from becoming addicted to nicotine or to reduce the likelihood of nicotine addiction. The claimed subject matter encompasses both pharmaceutical compositions and corresponding unit dosage forms.
Experimental and observational findings demonstrate that PPARγ agonist treatment is associated with reduced addictive-agent consumption, relapse, and withdrawal symptoms. Administration of PPARγ agonists, particularly pioglitazone, reduces nicotine self-administration and nicotine-seeking behavior, alongside documented smoking reductions in a human pilot study. Associated findings also report effects on ethanol intake, cocaine self-administration, and opioid behaviors including morphine tolerance and heroin acquisition.
Claims Coverage
The claims recite two independent claims providing two inventive features directed to compositions combining nicotine with a thiazolidinedione peroxisome proliferator-activated receptor gamma agonist.
Pharmaceutical composition combining nicotine and a TZD PPARγ agonist
Independent claim 1 covers a pharmaceutical composition comprising an effective amount of nicotine in combination with an effective amount of a PPARγ agonist that is a TZD, wherein the amount of the agonist is effective in preventing the subject from becoming addicted to nicotine or reducing the likelihood of becoming addicted. Dependent claims identify pioglitazone, rosiglitazone, ciglitazone, troglitazone, englitazone, rivoglitazone, and darglidazone, specifying pioglitazone in particular.
Unit dosage form combining nicotine and a TZD PPARγ agonist
Independent claim 5 covers a unit dosage form comprising a pharmaceutical composition with an effective amount of nicotine in combination with an effective amount of a PPARγ agonist that is a TZD, wherein the amount of the agonist is effective in preventing the subject from becoming addicted to nicotine or reducing the likelihood of becoming addicted. Dependent claims identify pioglitazone, rosiglitazone, ciglitazone, troglitazone, englitazone, rivoglitazone, and darglidazone, specifying pioglitazone in particular.
In summary, the independent claims define a pharmaceutical composition and a unit dosage form comprising nicotine and a TZD PPARγ agonist, each configured to prevent or reduce the likelihood of nicotine addiction.
Stated Advantages
The claimed effective amount of the PPARγ agonist prevents a subject from becoming addicted to nicotine or reduces the likelihood of becoming addicted.
PPARγ agonist treatment, including pioglitazone administration, reduces addictive-agent consumption, nicotine self-administration, nicotine-seeking behavior, relapse, and withdrawal symptoms.
Documented Applications
Pharmaceutical compositions and unit dosage forms combining nicotine with a TZD PPARγ agonist for preventing nicotine addiction or reducing the likelihood of becoming addicted to nicotine.
Use of PPARγ agonists, including pioglitazone, for reducing nicotine self-administration, nicotine seeking, and smoking.
Use of PPARγ agonists in addressing ethanol intake, alcohol withdrawal symptoms, cocaine self-administration, morphine tolerance, and heroin acquisition.
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