Progesterone and Atomoxetine for Cocaine Cessation

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.

Study Overview

• Status: Withdrawn
• Conditions: Nicotine Dependence; Cocaine Dependence
• Intervention / Treatment: Drug: Placebo; Drug: Progesterone

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Sheila M Specker, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: November 30, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Cocaine-Related Disorders; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 1P50DA033942-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO