Cocaine DependenceNCT01741376
Progesterone and Atomoxetine for Cocaine Cessation
A study testing Progesterone in people with Cocaine Dependence and Nicotine Dependence, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine Dependence, Nicotine Dependence
- What is being tested?
- Progesterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
- Being tested
- Progesterone, Placebo
- Medical subject headings
- Cocaine-Related Disorders, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Progesterone 200 mg twice daily
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Placebo | Placebo comparator | Two placebos are given for 84 days. Receives: Drug: Placebo |
| Progesterone + Placebo | Active comparator | Progesterone (200 mg twice daily) and a placebo are given Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Cessation
Urine Test
Measured: Days 1 to 86
Secondary outcomes (1)
Impulsivity
Self report of the following subjective questionnaires: (1) Behavioral Inhibition Activation Scales, (2) Barratt Impulsivity Scale, and (3) Brief Self Control Scale.
Measured: Days 1 to 86
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: All clinical trials within the Department of Psychiatry at UMN were suspended and this study was withdrawn due to no enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheila M Specker, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741376
- Sponsor's protocol ID
- 1P50DA033942-01
- Status last verified
- Sep 2019
- First submitted
- 30 Nov 2012
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone and Atomoxetine for Cocaine Cessation
- ClinicalTrials.gov ID
- NCT01741376
- Acronym / sponsor ID
- 1P50DA033942-01
- Conditions
- Cocaine Dependence, Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: All clinical trials within the Department of Psychiatry at UMN were suspended and this study was withdrawn due to no enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + Placebo | Placebo comparator | Drug: PlaceboTwo placebos are given for 84 days. |
| Progesterone + Placebo | Active comparator | Drug: ProgesteroneProgesterone (200 mg twice daily) and a placebo are given |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProgesteroneProgesterone 200 mg twice daily | Drug | Progesterone + Placebo |
| Placebo | Drug | Placebo + Placebo |
Primary outcome
Cocaine Cessation
Time frame: Days 1 to 86
Urine Test
1 secondary outcome
Impulsivity
Time frame: Days 1 to 86
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila M Specker, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progesterone in people with Cocaine Dependence and Nicotine Dependence, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cocaine Cessation (time frame: Days 1 to 86). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.