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Progesterone and Atomoxetine for Cocaine Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01741376
Recruitment Status : Terminated (Cocaine use is no longer a substance of abuse in our geographic location)
First Posted : December 4, 2012
Last Update Posted : May 17, 2016
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Nicotine Dependence Drug: Progesterone Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Progesterone and Atomoxetine for Cocaine Cessation
Study Start Date : November 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo + Placebo
Two placebos are given for 84 days.
Drug: Placebo
Active Comparator: Progesterone + Placebo
Progesterone (200 mg twice daily) and a placebo are given
Drug: Progesterone
Progesterone 200 mg twice daily

Primary Outcome Measures :
  1. Cocaine Cessation [ Time Frame: Days 1 to 86 ]
    Urine Test

Secondary Outcome Measures :
  1. Impulsivity [ Time Frame: Days 1 to 86 ]
    Self report of the following subjective questionnaires: (1) Behavioral Inhibition Activation Scales, (2) Barratt Impulsivity Scale, and (3) Brief Self Control Scale.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01741376

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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
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Principal Investigator: Sheila M Specker, MD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT01741376     History of Changes
Other Study ID Numbers: 1P50DA033942-01 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Cocaine-Related Disorders
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Atomoxetine Hydrochloride
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents