Progesterone and Atomoxetine for Cocaine Cessation

Study Overview
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Brief Summary
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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.

Official Title
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Progesterone and Atomoxetine for Cocaine Cessation

Conditions
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Cocaine Dependence, Nicotine Dependence

Intervention / Treatment
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* Drug: Progesterone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo + Placebo<br>Two placebos are given for 84 days. | Drug: Placebo<br> <br> |
| Active Comparator: Progesterone + Placebo<br>Progesterone (200 mg twice daily) and a placebo are given | Drug: Progesterone<br>* Progesterone 200 mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine Cessation | Urine Test | Days 1 to 86 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |