Progesterone and Atomoxetine for Cocaine Cessation

Conditions:Smoking Cessation, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Age Range:18 - 60
Start Date:November 2012
End Date:November 2016
Contact:Sheila m Specker, MD

Use our guide to learn which trials are right for you!

The purpose of this study is to examine the role of progesterone (a hormone found in both
men and women) on stopping cocaine use. The study will examine whether the medication, in
combination with behavior therapy will decrease cocaine use, cigarette smoking, withdrawal
symptoms, impulsivity and stress.

Inclusion Criteria:

- Females between 18 and 45 and males between 18 and 60 years-of-age;

- Understand the study procedures and provide written informed consent;

- Meet DSM-IV criteria for cocaine or methamphetamine and nicotine dependence;

- Minimum of cocaine use 4 days/months over last 3 months;

- Minimum of 5 cigarettes/day for last twelve months;

- Stable psychiatric status;

- Stable medical status; Willing to use double-barrier contraception method if sexually
active and not surgically sterilized;

- Regular menstrual cycles (for females);

- No contraindications to progesterone treatment;

- Ability to participate fully in research elements for the duration of the trial.

Exclusion Criteria:

- DSM-IV diagnoses for current or lifetime psychotic disorders (unless substance
induced), bipolar disorder, current ADHD and other current substance dependence
(except nicotine dependence, or alcohol or cannabis dependence not exhibiting
withdrawal or other features requiring medical attention);

- Currently using nicotine pharmacotherapy preparations;

- history of thromboembolic events, diabetes, stroke, heart disease;

- Psychotropic medications other than stable doses of anti-depressants;

- Currently pregnant or nursing;

- Liver enzyme levels three times normal limits;

- Previous treatment with or adverse response to progesterone.

- Serious suicide attempt within preceding 2 years;

- Current use of exogenous hormones.

- Conditions contraindicated to progesterone treatment (including, but not limited to,
thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding
disorders, heart disease, diabetes, history of stroke, allergy to peanuts,
hypersensitive to progesterone and liver dysfunction).

- History of pheochromotytoma or narrow angle glaucoma,

- Current hypertension, tachycardia or clinically relevant ECG abnormalites;

- Allergy to peanuts,

- Current suicidality or need for emergency psychiatric treatment.
We found this trial at
Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-273-9806
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
Minneapolis, MN
Click here to add this to my saved trials