HealthyPhase 2NCT00075205
Rimonabant to Reduce Alcohol Consumption
A Phase 2 study testing SR141716 (Rimonabant) in people with Healthy and Alcohol Drinking, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
This study will examine whether Rimonabant, a drug that blocks cannabinoid-1 (CB1) receptors in the brain, affects alcohol consumption. Substances called endocannabinoids, which have many of the same effects of marijuana, bind to CB1 receptors. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Healthy, Alcohol Drinking
- What is being tested?
- SR141716 (Rimonabant)
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2003to 15 Mar 2007
- 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female healthy participants, between 21 and 45 years of age.
- Weight and Body Mass Index:
- Males: between 60 kg and 90 kg; Body Mass Index between 18 and 28.
- Females: between 45 kg and 80 kg; Body Mass Index between 18 and 28.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal vital signs after 10 minutes in supine position:
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- systolic blood pressure between 95 mmHg and 140 mmHg,
- diastolic blood pressure between 50 mmHg and 90 mmHg,
- heart rate between 45 bpm and 90 bpm.
- Normal 12-lead EKG, PR less than 210 ms, QRS less than 120 ms, QTcB(1) less than or equal to 430 ms for male and less than or equal to 450 ms for female (incomplete right bundle branch block can be accepted).
- Laboratory results should be within the normal range. Laboratory results which are found to be marginally outside the normal range (i.e., minor variances in the complete blood count (CBC) or electrolytes) will be clinically evaluated for relevance to this protocol. Liver functions must be less than two times normal.
- Written informed consent prior to study participation.
- Female participants of childbearing capability must use a double contraceptive method (such as oral contraceptives, condom with spermicide or intra-uterine device with spermicide) from the start of the study until two months post medication trial.
- Normal dietary habits and willingness to abstain from grapefruit juice consumption during the study. (Grapefruit juice inhibits hepatic enzymes which could potentially interfere with the metabolism of SR141716.)
- Must agree to abstain from the use of illicit drugs for the duration of the study.
Who cannot join
- Any history or presence of significant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic (including any history of convulsions), systemic, infectious diseases, or psychiatric disorders (i.e., a current diagnosis of major depression, panic disorder, eating disorders, or history of schizophrenia, bipolar disorder, or obsessive compulsive disorder). Individuals who report suicidal ideation or who have a past history of suicide attempts.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
- Symptomatic hypotension whenever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (SBP) equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position.
- Blood donation within three months before administration.
- Presence or history of any allergy or unusual reactions to drugs or anesthetics that would suggest the participant could have a problem tolerating SR141716 or placebo.
- A participant who, in the judgment of the Investigator, is likely to be non-compliant, is violent when drinking, or is unable to cooperate because of a language problem or poor mental development.
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- Participant who cannot be contacted in case of emergency.
- Currently taking any prescription medications or over-the-counter medications on a regular basis. Participants will be allowed to take an occasional pain medication or an antibiotic, if they get sick during their participation in the protocol.
- Excessive consumption of beverages with xanthine bases (greater than 6 cups or glasses/day).
- Female participants who have a positive Beta-HCG test (urine and/or plasma) or who are lactating.
- Positive reaction to any of the following tests: HBs antigen, anti-HCVantibody, anti-HIV1 antibodies, anti-HIV2 antibodies. (Hepatitis could interfere with the metabolism of SR141716 in the liver. HIV could alter brain function.)
- Positive results of screening for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates).
- A DSM-IV diagnosis of illicit drug dependence in the last 6 months.
- Participants who come to the NIAAA Clinic and evidence withdrawal symptoms that result in a score of 8 or above on the CIWA Instrument.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Clinical Trial of the Cannabinoid CB1 Receptor Antagonist, SR141716 (Rimonabant), to Reduce Voluntary Ethanol Drinking in Healthy, Non-Treatment Seeking Individuals Who Consume Between 20 and 50 Drinks Per Week
This study will examine whether Rimonabant, a drug that blocks cannabinoid-1 (CB1) receptors in the brain, affects alcohol consumption. Substances called endocannabinoids, which have many of the same effects of marijuana, bind to CB1 receptors. Animal studies show that when CB1 receptors are blocked, the animals consume less alcohol.
Healthy normal volunteers between 21 and 40 years of age who consume between 20 and 40 alcoholic drinks per week, drink at least 4 days a week, and are not seeking treatment for alcoholism may be eligible for this study. Candidates are screened with a medical history, including questions about alcohol and drug use, physical examination, blood and urine tests, breath alcohol test, and electrocardiogram.
Read more
Participants are asked about their mental health history and use of alcohol, cigarettes and illicit drugs, and fill out questionnaires evaluating their emotional state and personality. Then, they begin a baseline evaluation in which they call a number at the NIH Clinical Center for 21 days to report how much alcohol they drank that day. One week after starting the baseline evaluation, they are randomly assigned to take either Rimonabant or placebo (a pill with no active ingredient) for 2 weeks. Before starting the drug, they have a urine drug screen and measurement of blood alcohol level. After 1 week on the test medication, they return to the Clinical Center to monitor drug or placebo side effects, if any, and to have a blood alcohol level test, urine drug screen, and blood tests for routine blood chemistries. After 2 weeks on the test medication, they come to the Clinical Center at noon for an alcohol self-administration test. Before the test, they are given a breath alcohol test and a urine drug test. The results of both tests must be negative to continue in the study.
The alcohol self-administration test is videotaped. A heparin lock is placed in a vein in the participant's arm. This small needle remains in the arm for the duration of the study to avoid multiple needle sticks for blood draws. Blood is drawn periodically during the test to determine routine laboratory values, cotinine level (assessment of smoking status), the amount of Rimonabant or placebo in the body, and levels of various hormones. Thirty minutes before the test begins and every 30 minutes during the test, participants complete questionnaires and rating scales regarding their mood and desire to drink. Five minutes before the test be...
Read the detailed description
Recent studies show that endogenous cannabinoids modulate appetitive behaviors. For example, an antagonist of the CB1 cannabinoid receptor, SR141716, decreases food intake in animals as well as in humans and decreases alcohol consumption in rodent models of voluntary ethanol consumption. In this protocol, individuals consuming between 20 and 40 alcohol drinks per week, and who are not seeking alcohol treatment, will be recruited from the community. Following a one week baseline evaluation, participants will be randomized according to a double-blind design to receive either placebo or SR141716 for two additional weeks prior to being admitted to the hospital to participate in an alcohol self-administration experiment. The design of this experiment has been previously shown by O'Malley et al. (1) to be an effective paradigm to study the effects of medication on alcohol consumption. Following baseline psychological and endocrine measures, participants will receive a priming dose of ethanol designed to raise the breath alcohol levels (BAL) to 0.03 g/dl and then have the opportunity to consume up to eight drinks or to receive $3 dollars for each drink not consumed over a two hour period. It is hypothesized that participants receiving SR141716, compared to those receiving placebo, will have decreased alcohol consumption. Following the study, each participant will be carefully counseled about their alcohol consumption and provided referrals for alcohol treatment.
- Conditions
- Healthy, Alcohol Drinking
- Being tested
- SR141716 (Rimonabant)
- Keywords
- Alcohol Consumption, Alcohol Treatment, Medication Trial, Craving, Cannabinoids, CB 1 Receptor Antagonist, SR141716, Alcoholism
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR141716 (Rimonabant)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2004 (estimated)
- Study start31 Dec 2003
- Primary completion15 Mar 2007
- Study completion15 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Sanofi-Synthelabo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075205
- Sponsor's protocol ID
- 040072
- Other IDs
- 04-AA-0072
- Status last verified
- 2 Jun 2010
- First submitted
- 5 Jan 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
O'Malley SS, Krishnan-Sarin S, Farren C, Sinha R, Kreek MJ. Naltrexone decreases craving and alcohol self-administration in alcohol-dependent subjects and activates the hypothalamo-pituitary-adrenocortical axis. Psychopharmacology (Berl). 2002 Feb;160(1):19-29. doi: 10.1007/s002130100919. Epub 2002 Jan 22.
PubMed 11862370Schwartz MW, Woods SC, Porte D Jr, Seeley RJ, Baskin DG. Central nervous system control of food intake. Nature. 2000 Apr 6;404(6778):661-71. doi: 10.1038/35007534.
PubMed 10766253Levine AS, Morley JE. Neuropeptide Y: a potent inducer of consummatory behavior in rats. Peptides. 1984 Nov-Dec;5(6):1025-9. doi: 10.1016/0196-9781(84)90165-7.
PubMed 6549409
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the Cannabinoid CB1 Receptor Antagonist, SR141716 (Rimonabant), to Reduce Voluntary Ethanol Drinking in Healthy, Non-Treatment Seeking Individuals Who Consume Between 20 and 50 Drinks Per Week
- ClinicalTrials.gov ID
- NCT00075205
- Acronym / sponsor ID
- 040072
- Conditions
- Healthy, Alcohol Drinking
- Keywords
- Alcohol Consumption, Alcohol Treatment, Medication Trial, Craving, Cannabinoids, CB 1 Receptor Antagonist, SR141716, Alcoholism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Collaborators
- Sanofi-Synthelabo
- Study start
- 31 Dec 2003
- Primary completion
- 15 Mar 2007 (actual)
- Study completion
- 15 Mar 2007 (actual)
- First posted
- 6 Jan 2004 (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.
This study will examine whether Rimonabant, a drug that blocks cannabinoid-1 (CB1) receptors in the brain, affects alcohol consumption. Substances called endocannabinoids, which have many of the same effects of marijuana, bind to CB1 receptors. Animal studies show that when CB1 receptors are blocked, the animals consume less alcohol.
Healthy normal volunteers between 21 and 40 years of age who consume between 20 and 40 alcoholic drinks per week, drink at least 4 days a week, and are not seeking treatment for alcoholism may be eligible for this study. Candidates are screened with a medical history, including questions about alcohol and drug use, physical examination, blood and urine tests, breath alcohol test, and electrocardiogram.
Participants are asked about their mental health history and use of alcohol, cigarettes and illicit drugs, and fill out questionnaires evaluating their emotional state and personality. Then, they begin a baseline evaluation in which they call a number at the NIH Clinical Center for 21 days to report how much alcohol they drank that day. One week after starting the baseline evaluation, they are randomly assigned to take either Rimonabant or placebo (a pill with no active ingredient) for 2 weeks. Before starting the drug, they have a urine drug screen and measurement of blood alcohol level. After 1 week on the test medication, they return to the Clinical Center to monitor drug or placebo side effects, if any, and to have a blood alcohol level test, urine drug screen, and blood tests for routine blood chemistries. After 2 weeks on the test medication, they come to the Clinical Center at noon for an alcohol self-administration test. Before the test, they are given a breath alcohol test and a urine drug test. The results of both tests must be negative to continue in the study.
The alcohol self-administration test is videotaped. A heparin lock is placed in a vein in the participant's arm. This small needle remains in the arm for the duration of the study to avoid multiple needle sticks for blood draws. Blood is drawn periodically during the test to determine routine laboratory values, cotinine level (assessment of smoking status), the amount of Rimonabant or placebo in the body, and levels of various hormones. Thirty minutes before the test begins and every 30 minutes during the test, participants complete questionnaires and rating scales regarding their mood and desire to drink. Five minutes before the test be...
Detailed description
Recent studies show that endogenous cannabinoids modulate appetitive behaviors. For example, an antagonist of the CB1 cannabinoid receptor, SR141716, decreases food intake in animals as well as in humans and decreases alcohol consumption in rodent models of voluntary ethanol consumption. In this protocol, individuals consuming between 20 and 40 alcohol drinks per week, and who are not seeking alcohol treatment, will be recruited from the community. Following a one week baseline evaluation, participants will be randomized according to a double-blind design to receive either placebo or SR141716 for two additional weeks prior to being admitted to the hospital to participate in an alcohol self-administration experiment. The design of this experiment has been previously shown by O'Malley et al. (1) to be an effective paradigm to study the effects of medication on alcohol consumption. Following baseline psychological and endocrine measures, participants will receive a priming dose of ethanol designed to raise the breath alcohol levels (BAL) to 0.03 g/dl and then have the opportunity to consume up to eight drinks or to receive $3 dollars for each drink not consumed over a two hour period. It is hypothesized that participants receiving SR141716, compared to those receiving placebo, will have decreased alcohol consumption. Following the study, each participant will be carefully counseled about their alcohol consumption and provided referrals for alcohol treatment.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male and female healthy participants, between 21 and 45 years of age.
- Males: between 60 kg and 90 kg; Body Mass Index between 18 and 28.
- Females: between 45 kg and 80 kg; Body Mass Index between 18 and 28.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- systolic blood pressure between 95 mmHg and 140 mmHg,
Key exclusion criteria (14 listed)
- Any history or presence of significant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic (including any history of convulsions), systemic, infectious diseases, or psychiatric disorders (i.e., a current diagnosis of major depression, panic disorder, eating disorders, or history of schizophrenia, bipolar disorder, or obsessive compulsive disorder). Individuals who report suicidal ideation or who have a past history of suicide attempts.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
- Symptomatic hypotension whenever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (SBP) equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position.
- Blood donation within three months before administration.
- Presence or history of any allergy or unusual reactions to drugs or anesthetics that would suggest the participant could have a problem tolerating SR141716 or placebo.
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 |
|---|---|---|
| SR141716 (Rimonabant) | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 11862370O'Malley SS, Krishnan-Sarin S, Farren C, Sinha R, Kreek MJ. Naltrexone decreases craving and alcohol self-administration in alcohol-dependent subjects and activates the hypothalamo-pituitary-adrenocortical axis. Psychopharmacology (Berl). 2002 Feb;160(1):19-29. doi: 10.1007/s002130100919. Epub 2002 Jan 22.
- Background: PubMed 10766253Schwartz MW, Woods SC, Porte D Jr, Seeley RJ, Baskin DG. Central nervous system control of food intake. Nature. 2000 Apr 6;404(6778):661-71. doi: 10.1038/35007534.
- Background: PubMed 6549409Levine AS, Morley JE. Neuropeptide Y: a potent inducer of consummatory behavior in rats. Peptides. 1984 Nov-Dec;5(6):1025-9. doi: 10.1016/0196-9781(84)90165-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SR141716 (Rimonabant) in people with Healthy and Alcohol Drinking, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 15 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: finished, as of the sponsor's last update on 2 Jul 2017. 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00075205, which also lists 3 linked publications.
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 2 Jul 2017.