Progesterone and Atomoxetine for Cocaine Cessation

Nicotine Dependence Clinical Trial

Official title:

Progesterone and Atomoxetine for Cocaine Cessation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01741376
• Other study ID #: 1P50DA033942-01
• Status: Withdrawn
• Phase: N/A
• Start date: November 2012
• Est. completion date: November 2012

Study information

• Verified date: September 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders
• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Progesterone
Progesterone 200 mg twice daily
• Placebo

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine Cessation	Urine Test	Days 1 to 86
Secondary	Impulsivity	Self report of the following subjective questionnaires: (1) Behavioral Inhibition Activation Scales, (2) Barratt Impulsivity Scale, and (3) Brief Self Control Scale.	Days 1 to 86