Progesterone and Atomoxetine for Cocaine Cessation

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Cocaine Dependence, Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT01741376

Run by

University of Minnesota

People needed

0

Starts

2012-11-01

Expected to finish

2012-11-01

Last updated by the study team

2019-09-06

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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