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Progesterone and Atomoxetine for Cocaine Cessation

Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Dependence; Nicotine Dependence

Intervention: Progesterone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Minnesota - Clinical and Translational Science Institute

Official(s) and/or principal investigator(s):
Sheila M Specker, MD, Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute

Overall contact:
Sheila m Specker, MD, Phone: 612-273-9806, Email: speck001@umn.edu


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.

Clinical Details

Official title: Progesterone and Atomoxetine for Cocaine Cessation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Cocaine Cessation

Secondary outcome: Impulsivity


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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.

Locations and Contacts

Sheila m Specker, MD, Phone: 612-273-9806, Email: speck001@umn.edu

University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Sheila M. Specker, MD, Phone: 612-273-9806, Email: speck001@umn.edu
Additional Information

Starting date: November 2012
Last updated: July 6, 2015

Page last updated: August 23, 2015

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