Progesterone and Atomoxetine for Cocaine Cessation

NCT01741376 | Withdrawn DMC

• 1 other identifier: 1P50DA033942-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cocaine Cessation

  Urine Test

  Days 1 to 86

Secondary Outcomes (1)

• Impulsivity

  Days 1 to 86

Study Arms (2)

Placebo + Placebo

PLACEBO COMPARATOR

Two placebos are given for 84 days.

Drug: Placebo

Progesterone + Placebo

ACTIVE COMPARATOR

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

Drug: Progesterone

Interventions

Progesterone DRUG

Progesterone 200 mg twice daily

Progesterone + Placebo

Placebo DRUG

Placebo + Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Tobacco Use Disorder

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Sheila M Specker, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)