Clinical trial NCT01741376: Progesterone and Atomoxetine for Cocaine Cessation
Official title: Progesterone and Atomoxetine for Cocaine Cessation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cocaine Dependence
Nicotine Dependence
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Cocaine Cessation
timeFrame: Days 1 to 86
Secondary outcomes:
measure: Impulsivity
timeFrame: Days 1 to 86
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sheila M Specker, MD
role: PRINCIPAL_INVESTIGATOR
References: