Progesterone and Atomoxetine for Cocaine Cessation

NCT ID: NCT01741376

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2012-11-30

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.

Conditions

Cocaine Dependence; Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo + Placebo

Two placebos are given for 84 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Progesterone + Placebo

Progesterone (200 mg twice daily) and a placebo are given

Group Type: ACTIVE_COMPARATOR

Progesterone

Intervention Type: DRUG

Progesterone 200 mg twice daily

Interventions

Progesterone

Progesterone 200 mg twice daily

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheila M Specker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1P50DA033942-01

Identifier Type: NIH

Identifier Source: org_study_id

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