Substance Withdrawal SyndromePhase 2DHEANCT00900900

The Effects of One-Time Pregnenolone, Dehydroepiandrosterone (DHEA), or Placebo Administration On Withdrawal Symptoms, Mood, Craving And Cigarette Evaluation Ratings In Male Smokers

A Phase 2 study testing dehydroepiandrosterone (DHEA) and pregnenolone in people with Substance Withdrawal Syndrome, run by Jed E. Rose at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the potential therapeutic value of two neurosteroid treatments (DHEA and pregnenolone) in the treatment of tobacco withdrawal symptoms. This will include assessing whether these agents relieve craving for cigarettes elicited by exposure to a mildly stressful cognitive task. Read more about this study

Who is it for?: Ages 18 to 65 years, men only
Conditions the study is for: Substance Withdrawal Syndrome
What is being tested?: dehydroepiandrosterone (DHEA) and pregnenolone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 2 sitesUnited States
Study dates: Jul 2009to Mar 2011
Phase: Phase 2
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 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

male;
18-65 years old;
smoked an average of at least 10 cigarettes per day for three cumulative or continuous years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5 mg nicotine;
afternoon expired carbon monoxide reading of at least 10 ppm;
in general good health, based on physical examination, EKG serum chemistries, CBC and urinalysis.

Who cannot join

Participants must not have uncontrolled hypertension (systolic >140 mm Hg, diastolic >95 mm Hg)
hypotension (systolic <90 mm Hg, diastolic <60 mm Hg);
coronary heart disease;
heart attack;
cardiac rhythm disorder (irregular heart rhythm);
chest pains (unless history, exam, and EKG clearly indicate a non-cardiac source);

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cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
liver or kidney disorder (except kidney stones, gallstones);
gastrointestinal problems or disease other than gastroesophageal reflux,
heartburn, or irritable bowel syndrome;
ulcers within the past 6 months;
lung disorder (including but not limited to COPD, emphysema, and asthma);
brain abnormality (including but not limited to, stroke, brain tumor, seizure disorder);
history of fainting;
problems giving blood samples;
diabetes;
current cancer or treatment for cancer in the past 6 months (except basal or squamous cell skin cancer);
other major medical condition;
major depression, panic disorder, anxiety, bipolar disorder, schizophrenia, risk of suicide, or substance dependence other than nicotine dependence;
subjects who endorse suicidal ideation on the MINI abridged;
alcohol or drugs abuse;
reported use of illicit drugs within the past 30 days, or if the drug screen is positive;
reported use of smokeless tobacco (chewing tobacco, snuff), cigars, pipes, or nicotine replacement therapy; testosterone replacement therapy, DHEA or Pregnenolone; experimental (investigational) drugs; psychiatric medications (including antidepressants, anti-anxiety agents. anti-psychotics), sleep aids, medications that increase DHEA and/or DHEA-S concentrations (including, but not limited to: diltiazem, benfluorex, amlodipine, alprazolam, danazol, metformin, nitrendipine and retinol), or any other medications that are known to affect smoking (e.g. clonidine, muscle relaxants, opiate pain medications) within the past 2 weeks.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Duke Center for Nicotine & Smoking Cessation Research
Durham, North Carolina, 27705
Duke Center for Nicotine & Smoking Cessation Research
Raleigh, North Carolina, 27609

Other trials in United States

About this study

Official title: The Effects of One-Time Pregnenolone, DHEA, Or Placebo Administration On Withdrawal Symptoms, Mood, Craving And Cigarette Evaluation Ratings In Male Smokers

Conditions: Substance Withdrawal Syndrome
Being tested: dehydroepiandrosterone (DHEA), pregnenolone, Placebo
Keywords: Cigarette Smokers, DHEA, dehydroepiandrosterone, pregnenolone, Nicotine withdrawal symptoms
Medical subject headings: Substance Withdrawal Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dehydroepiandrosterone (DHEA)Dietary supplement
one-time 400mg oral dose of DHEA
pregnenoloneDietary supplement
one-time 400mg oral dose of pregnenolone
PlaceboDrug
one-time dose oral dose

Study groups in NCT00900900
Study group	Role	What they receive
Dehydroepiandrosterone (DHEA)	Experimental	Not described Receives: Dietary Supplement: dehydroepiandrosterone (DHEA)
Pregnenolone	Experimental	Not described Receives: Dietary Supplement: pregnenolone
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The administration of DHEA or pregnenolone will reduce smoking withdrawal symptoms.
Measured: 6 months

Secondary outcomes (2)

The administration of DHEA or pregnenolone will reduce the subjective rewarding effects of nicotine inhaled in cigarette smoke.
Measured: 6 months
The administration of DHEA or pregnenolone will reduce stress-induced changes in mood and craving for cigarettes.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Mar 2011

First posted13 May 2009 (estimated)
Study startJul 2009
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Substance Withdrawal SyndromeStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00900900
Sponsor's protocol ID: Pro00008225
Acronym: DHEA
Status last verified: Sep 2012
First submitted: 11 May 2009
Last updated: 21 Sep 2012
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
Opioid Use Disorder
Not yet recruitingPhase 4
Evaluation of Dependence and Nicotine Replacement Therapy-Supported Cessation Efforts Among Regular Electronic Cigarette Use
E Cigarette Use, Cessation, Tobacco
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All Substance Withdrawal Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of One-Time Pregnenolone, DHEA, Or Placebo Administration On Withdrawal Symptoms, Mood, Craving And Cigarette Evaluation Ratings In Male Smokers
ClinicalTrials.gov ID: NCT00900900
Acronym / sponsor ID: DHEA / Pro00008225
Conditions: Substance Withdrawal Syndrome
Keywords: Cigarette Smokers, DHEA, dehydroepiandrosterone, pregnenolone, Nicotine withdrawal symptoms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Jed E. RoseUniversity, hospital or other
Study start: Jul 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 13 May 2009 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Dehydroepiandrosterone (DHEA)	Experimental	Dietary Supplement: dehydroepiandrosterone (DHEA)
Pregnenolone	Experimental	Dietary Supplement: pregnenolone
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

male;
18-65 years old;
smoked an average of at least 10 cigarettes per day for three cumulative or continuous years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5 mg nicotine;
afternoon expired carbon monoxide reading of at least 10 ppm;
in general good health, based on physical examination, EKG serum chemistries, CBC and urinalysis.

Key exclusion criteria (23 listed)

Participants must not have uncontrolled hypertension (systolic >140 mm Hg, diastolic >95 mm Hg)
hypotension (systolic <90 mm Hg, diastolic <60 mm Hg);
coronary heart disease;
heart attack;
cardiac rhythm disorder (irregular heart rhythm);

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
dehydroepiandrosterone (DHEA)one-time 400mg oral dose of DHEA	Dietary supplement	Dehydroepiandrosterone (DHEA)
pregnenoloneone-time 400mg oral dose of pregnenolone	Dietary supplement	Pregnenolone
Placeboone-time dose oral dose	Drug	Placebo

Primary outcome

The administration of DHEA or pregnenolone will reduce smoking withdrawal symptoms.
Time frame: 6 months

2 secondary outcomes

The administration of DHEA or pregnenolone will reduce the subjective rewarding effects of nicotine inhaled in cigarette smoke.
Time frame: 6 months
The administration of DHEA or pregnenolone will reduce stress-induced changes in mood and craving for cigarettes.
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2012.

Related trials for Substance Withdrawal Syndrome

Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Not yet recruiting
Preventox - a Digital Intervention for Patients With Intoxications in Intensive Care
Intoxication, Delirium Tremens (DTs)
RecruitingPhase 1
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
Opioid Use Disorder
Not yet recruitingPhase 4
Evaluation of Dependence and Nicotine Replacement Therapy-Supported Cessation Efforts Among Regular Electronic Cigarette Use
E Cigarette Use, Cessation, Tobacco
Not yet recruitingPhase 2/3
Dexmedetomidine for Invasive Ventilation In the NEOnate
Invasive Ventilation, Infant Pain

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.

Jed E Rose, Ph.D. principal investigator

Duke University

Christine Marx, M.D. principal investigator

Duke University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dehydroepiandrosterone (DHEA) and pregnenolone in people with Substance Withdrawal Syndrome, run by Jed E. Rose at 2 sites 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 5 inclusion and 23 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: finished, as of the sponsor's last update on 21 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The administration of DHEA or pregnenolone will reduce smoking withdrawal symptoms. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00900900.

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 21 Sep 2012.