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Progesterone and Atomoxetine for Cocaine Cessation

Primary Purpose

Cocaine Dependence, Nicotine Dependence

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progesterone
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo + Placebo

Progesterone + Placebo

Arm Description

Two placebos are given for 84 days.

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

Outcomes

Primary Outcome Measures

Cocaine Cessation
Urine Test

Secondary Outcome Measures

Impulsivity
Self report of the following subjective questionnaires: (1) Behavioral Inhibition Activation Scales, (2) Barratt Impulsivity Scale, and (3) Brief Self Control Scale.

Full Information

First Posted
November 30, 2012
Last Updated
September 3, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01741376
Brief Title
Progesterone and Atomoxetine for Cocaine Cessation
Official Title
Progesterone and Atomoxetine for Cocaine Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
All clinical trials within the Department of Psychiatry at UMN were suspended and this study was withdrawn due to no enrollment.
Study Start Date
November 2012 (Actual)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence, Nicotine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + Placebo
Arm Type
Placebo Comparator
Arm Description
Two placebos are given for 84 days.
Arm Title
Progesterone + Placebo
Arm Type
Active Comparator
Arm Description
Progesterone (200 mg twice daily) and a placebo are given
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
Progesterone 200 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Cocaine Cessation
Description
Urine Test
Time Frame
Days 1 to 86
Secondary Outcome Measure Information:
Title
Impulsivity
Description
Self report of the following subjective questionnaires: (1) Behavioral Inhibition Activation Scales, (2) Barratt Impulsivity Scale, and (3) Brief Self Control Scale.
Time Frame
Days 1 to 86

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila M Specker, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Progesterone and Atomoxetine for Cocaine Cessation

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