Page last updated: 2024-11-03

ritanserin and Alcoholism

ritanserin has been researched along with Alcoholism in 12 studies

Ritanserin: A selective and potent serotonin-2 antagonist that is effective in the treatment of a variety of syndromes related to anxiety and depression. The drug also improves the subjective quality of sleep and decreases portal pressure.
ritanserin : A thiazolopyrimidine that is 5H-[1,3]thiazolo[3,2-a]pyrimidin-5-one which is substituted at position 7 by a methyl group and at position 6 by a 2-{4-[bis(4-fluorophenyl)methylidene]piperidin-1-yl}ethyl group. A potent and long-acting seratonin (5-hydroxytryptamine, 5-HT) antagonist of the subtype 5-HT2 (Ki = 0.39 nM), it is used in the treatment of a variety of disorders including anxiety, depression and schizophrenia. It has little sedative action.

Alcoholism: A primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. It is characterized by impaired control over drinking, preoccupation with the drug alcohol, use of alcohol despite adverse consequences, and distortions in thinking, most notably denial. Each of these symptoms may be continuous or periodic. (Morse & Flavin for the Joint Commission of the National Council on Alcoholism and Drug Dependence and the American Society of Addiction Medicine to Study the Definition and Criteria for the Diagnosis of Alcoholism: in JAMA 1992;268:1012-4)

Research Excerpts

ExcerptRelevanceReference
"Ritanserin was well tolerated."6.69Ritanserin in relapse prevention in abstinent alcoholics: results from a placebo-controlled double-blind international multicenter trial. Ritanserin in Alcoholism Work Group. ( Boening, J; Chick, J; Naranjo, CA; Weijers, HG; Wiesbeck, GA, 1999)
"Ritanserin is a potent long-acting 5-HT2 antagonist that acts centrally."6.39Ritanserin and alcohol abuse and dependence. ( Meert, TF, 1994)
" Currently, a full clinical development program of ritanserin in cocaine and alcohol abuse is ongoing."6.17Addiction and the potential for therapeutic drug development. ( Janssen, PA, 1994)
"Ritanserin was well tolerated."2.69Ritanserin in relapse prevention in abstinent alcoholics: results from a placebo-controlled double-blind international multicenter trial. Ritanserin in Alcoholism Work Group. ( Boening, J; Chick, J; Naranjo, CA; Weijers, HG; Wiesbeck, GA, 1999)
"Ritanserin treatment was associated with a dose-related prolongation of subjects' QTc interval recording on the electrocardiogram."2.68Ritanserin in the treatment of alcohol dependence--a multi-center clinical trial. Ritanserin Study Group. ( Anton, RF; Bohn, MJ; Clyde, C; Galloway, GP; Jasinski, DR; Johnson, BA; Kranzler, H; Mason, BJ; Pettinati, HM; Rawson, R; Weinreib, R, 1996)
"Ritanserin was given at a daily dose of 10 mg for 28 days and was preceded (10 days) and followed (2 days) by a placebo."2.67The effects of ritanserin on mood and sleep in abstinent alcoholic patients. ( Alterwain, P; Alvariño, F; Estévez, F; Giusti, M; Labraga, P; Monti, JM; Olivera, S, 1993)
"Acamprosate has demonstrated efficacy for treating alcohol dependence in European trials, but with a small effect size."2.44Update on neuropharmacological treatments for alcoholism: scientific basis and clinical findings. ( Johnson, BA, 2008)
"Ritanserin is a potent long-acting 5-HT2 antagonist that acts centrally."2.39Ritanserin and alcohol abuse and dependence. ( Meert, TF, 1994)
"Ritanserin is a thymosthenic agent with an extensive hepatic metabolism and long elimination half life in healthy volunteers."1.29Ritanserin pharmacokinetics in abstinent chronic alcoholics. ( Estévez, F; Giusti, M; Monti, J, 1995)
"Buspirone was without important effects on the high alcohol preferring rats."1.29Effects of various serotonergic agents on alcohol intake and alcohol preference in Wistar rats selected at two different levels of alcohol preference. ( Meert, TF, 1993)

Research

Studies (12)

TimeframeStudies, this research(%)All Research%
pre-19901 (8.33)18.7374
1990's9 (75.00)18.2507
2000's2 (16.67)29.6817
2010's0 (0.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Johnson, BA2
Estévez, F2
Giusti, M2
Monti, J1
Naranjo, CA2
Poulos, CX1
Lanctôt, KL1
Bremner, KE1
Kwok, M1
Umana, M1
Janssen, PA1
Monti, JM2
Alterwain, P2
Alvariño, F1
Olivera, S1
Labraga, P1
Meert, TF2
Jasinski, DR1
Galloway, GP1
Kranzler, H1
Weinreib, R1
Anton, RF1
Mason, BJ1
Bohn, MJ1
Pettinati, HM1
Rawson, R1
Clyde, C1
Wiesbeck, GA1
Weijers, HG1
Chick, J1
Boening, J1
Myrick, H1
Brady, KT1
Malcolm, R1
Simonsson, P1
Alling, C1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence[NCT01549652]133 participants (Actual)Interventional2011-04-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Beck Depression Inventory Score (BDIS) Change From Baseline (Prevention of Opioid Withdrawal)

The Beck Depression Inventory (a 21-item self-report multiple-choice inventory) yields a single summed score between 0 and 63; higher scores indicate more severe depression. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken prior to receiving ondansetron or placebo, at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Prevention of Opioid Withdrawal-0.44

Change in Pain Visual Analog Scale (VAS) From Baseline (Prevention of Opioid Withdrawal)

The VAS is a 0 to 100 millimeter scale where 0 corresponds to no pain and 100 to extreme pain, used by participants to indicated their level of pain over the last two weeks. Change is from baseline score for average level of pain (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken prior to receiving ondansetron or placebo, at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Prevention of Opioid Withdrawal-2.68

Change in Roland-Morris Disability Index (RMDI) From Baseline (Prevention of Opioid Withdrawal)

The Roland-Morris Disability Index is a 24-question instrument used to assess level of disability from lower back pain. Scores range from 0-24 with lower scores corresponding to fewer symptoms. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken prior to receiving ondansetron or placebo, at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Prevention of Opioid Withdrawal-2.59

Beck Depression Inventory Score (BDIS) Change From Baseline (Prevention of Physical Dependence)

The Beck Depression Inventory (a 21-item self-report multiple-choice inventory) yields a single summed score between 0 and 63; higher scores indicate more severe depression. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Change in BDIS (Ondansetron)Change in BDIS (Placebo)
Prevention of Physical Dependence-0.60.2

Change in Objective Opioid Withdrawal Score (OOWS) From Baseline (Prevention of Opioid Withdrawal)

"Originally developed by Handelsman, the Objective Opioid Withdrawal Scale (OOWS) score is a well-characterized measure of opioid withdrawal in humans, calculated as the sum of a 13-item physician assessment documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. The minimum score of 0 means the patient is not showing any signs of opioid withdrawal. The maximum score of 13 signifies all signs of opioid withdrawal to the largest extent possible.~Immediately prior to ondansetron or placebo administration a baseline OOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an OOWS score was taken. If deemed necessary by the clinician, participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an OOWS score was taken. Change from the baseline OOWS score to the score assessed following the last naloxone dose is reported." (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in OOWS (Ondansetron)Change in OOWS (Placebo)
Prevention of Opioid Withdrawal3.63.6

Change in Objective Opioid Withdrawal Score From Baseline (Prevention of Physical Dependence)

"Originally developed by Handelsman, the OOWS score is a well-characterized measure of opioid withdrawal in humans, calculated as the sum of a 13-item physician assessment documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. The maximum score is 13 and suggests the patient is showing all signs of opioid withdrawal to the largest extent possible. The minimum score of 0 suggests the patient is not showing any signs of opioid withdrawal.~Immediately prior to ondansetron or placebo administration a baseline OOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an OOWS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an OOWS score was taken. Change from the baseline OOWS score to the score assessed following the last naloxone dose is reported." (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in OOWS (Ondansetron)Change in OOWS (Placebo)
Prevention of Physical Dependence4.54.2

Change in Pain Visual Analog Scale (VAS) From Baseline (Prevention of Physical Dependence)

The VAS is a 0 to 100 millimeter scale where 0 corresponds to no pain and 100 to extreme pain, used by participants to indicated their level of pain over the last two weeks. Change is from baseline score for average level of pain (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Change in VAS Score (Ondansetron)Change in VAS Score (Placebo)
Prevention of Physical Dependence-2.9-2.8

Change in Roland-Morris Disability (RMDI) Index From Baseline (Prevention of Physical Dependence)

The Roland-Morris Disability Index is a 24-question instrument used to assess level of disability from lower back pain. Scores range from 0-24 with lower scores corresponding to fewer symptoms. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken at the beginning of second study visit). (NCT01549652)
Timeframe: 2 study days 1 month apart (at the start of each study visit)

Interventionunits on a scale (Mean)
Change in RMDI (Ondansetron)Change in RMDI (Placebo)
Prevention of Physical Dependence-4.6-2.0

Change in Subjective Opioid Withdrawal Score (SOWS) From Baseline (Prevention of Opioid Withdrawal)

The Subjective Opioid Withdrawal Score (SOWS) score is calculated as the sum of 16 subjective patient-reported symptom scores rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. A maximum score of 64 would suggest the patient is experiencing the symptoms of withdrawal to the maximum extent possible while the lowest score of 0 would suggest the patient is not experiencing any of the symptoms of withdrawal. Immediately prior to ondansetron or placebo administration a baseline SOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an SOWS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an SOWS score was taken. Change from the baseline SOWS score to the score assessed following the last naloxone dose is reported (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in SOWS (Ondansetron)Change in SOWS (Placebo)
Prevention of Opioid Withdrawal12.512.2

Change in Subjective Opioid Withdrawal Score From Baseline (Prevention of Physical Dependence)

The SOWS score is composed of 16 subjective symptoms rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. A maximum score of 64 would suggest the patient is experiencing the symptoms of withdrawal to the maximum extent possible while the lowest score of 0 would suggest the patient is not experiencing any of the symptoms of withdrawal. Immediately prior to ondansetron or placebo administration a baseline SOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an SOWS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an SOWS score was taken. Change from the baseline SOWS score to the score assessed following the last naloxone dose is reported (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in SOWS (Ondansetron)Change in SOWS (Placebo)
Prevention of Physical Dependence16.412.0

Profile of Mood States (POMS) Change in Score From Baseline (Prevention of Opioid Withdrawal)

Profile of Mood States (POMS) is a 65-question survey of how participants have been feeling over the past week, assessing tension, depression, anger, fatigue, confusion and vigor. Each question is on a 5-point scale: 0 (not at all) to 4 (extremely). Overall score range: 0 to 200 (lower scores corresponding to fewer symptoms), calculated by adding total scores for tension, depression, anger, fatigue and confusing, and subtracting that total score from the total score for vigor. Immediately prior to ondansetron or placebo administration a baseline POMS score was taken. 30 minutes later participants received naloxone, then 15 minutes later a POMS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an POMS score was taken. Change from the baseline POMS score to the score assessed following the last naloxone dose is reported. (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in POMS Score (Ondansetron)Change in POMS Score (Placebo)
Prevention of Opioid Withdrawal29.328.3

Profile of Mood States (POMS) Change in Score From Baseline (Prevention of Physical Dependence)

(Profile of Mood States) POMS is a 65-question survey of how participants have been feeling over the past week, assessing tension, depression, anger, fatigue, confusion and vigor. Each question is on a 5-point scale: 0 (not at all) to 4 (extremely). Overall score range: 0 to 200 (lower scores corresponding to fewer symptoms), calculated by adding total scores for tension, depression, anger, fatigue and confusing, and subtracting that total score from the total score for vigor. Immediately prior to ondansetron or placebo administration a baseline POMS score was taken. 30 minutes later participants received naloxone, then 15 minutes later a POMS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an POMS score was taken. Change from the baseline POMS score to the score assessed following the last naloxone dose is reported. (NCT01549652)
Timeframe: Baseline; 15 minutes following last naloxone dose

Interventionunits on a scale (Mean)
Change in POMS (Ondansetron)Change in POMS (Placebo)
Prevention of Physical Dependence36.129.2

Reviews

4 reviews available for ritanserin and Alcoholism

ArticleYear
Update on neuropharmacological treatments for alcoholism: scientific basis and clinical findings.
    Biochemical pharmacology, 2008, Jan-01, Volume: 75, Issue:1

    Topics: Acamprosate; Alcoholism; Animals; Baclofen; Disulfiram; Fructose; Humans; Naltrexone; Ondansetron; R

2008
Addiction and the potential for therapeutic drug development.
    EXS, 1994, Volume: 71

    Topics: Alcoholism; Animals; Cocaine; Disease Models, Animal; Double-Blind Method; Humans; Research Design;

1994
Ritanserin and alcohol abuse and dependence.
    Alcohol and alcoholism (Oxford, Oxfordshire). Supplement, 1994, Volume: 2

    Topics: Alcohol Drinking; Alcoholism; Animals; Clinical Trials as Topic; Discrimination Learning; Disease Mo

1994
New developments in the pharmacotherapy of alcohol dependence.
    The American journal on addictions, 2001, Volume: 10, Issue:s1

    Topics: Acamprosate; Adjuvants, Anesthesia; Alcohol Deterrents; Alcoholism; Anticonvulsants; Buspirone; Carb

2001

Trials

5 trials available for ritanserin and Alcoholism

ArticleYear
Ritanserin, a central 5-HT2 antagonist, in heavy social drinkers: desire to drink, alcohol intake and related effects.
    Addiction (Abingdon, England), 1995, Volume: 90, Issue:7

    Topics: Adult; Alcohol Drinking; Alcoholism; Ambulatory Care; Dose-Response Relationship, Drug; Double-Blind

1995
Addiction and the potential for therapeutic drug development.
    EXS, 1994, Volume: 71

    Topics: Alcoholism; Animals; Cocaine; Disease Models, Animal; Double-Blind Method; Humans; Research Design;

1994
The effects of ritanserin on mood and sleep in abstinent alcoholic patients.
    Sleep, 1993, Volume: 16, Issue:7

    Topics: Adult; Affect; Alcoholism; Anxiety; Humans; Male; Middle Aged; Ritanserin; Sleep; Sleep Initiation a

1993
Ritanserin in the treatment of alcohol dependence--a multi-center clinical trial. Ritanserin Study Group.
    Psychopharmacology, 1996, Volume: 128, Issue:2

    Topics: Adult; Alcoholism; Double-Blind Method; Female; Headache; Humans; Male; Middle Aged; Rhinitis; Ritan

1996
Ritanserin in relapse prevention in abstinent alcoholics: results from a placebo-controlled double-blind international multicenter trial. Ritanserin in Alcoholism Work Group.
    Alcoholism, clinical and experimental research, 1999, Volume: 23, Issue:2

    Topics: Adult; Alcoholism; Double-Blind Method; Female; Humans; Male; Middle Aged; Recurrence; Ritanserin; S

1999

Other Studies

4 other studies available for ritanserin and Alcoholism

ArticleYear
Ritanserin pharmacokinetics in abstinent chronic alcoholics.
    Medicina, 1995, Volume: 55, Issue:1

    Topics: Adult; Alcoholism; Body Weight; Chromatography, Liquid; Female; Humans; Male; Metabolic Clearance Ra

1995
Effects of various serotonergic agents on alcohol intake and alcohol preference in Wistar rats selected at two different levels of alcohol preference.
    Alcohol and alcoholism (Oxford, Oxfordshire), 1993, Volume: 28, Issue:2

    Topics: Alcohol Drinking; Alcoholism; Animals; Buspirone; Chlordiazepoxide; Citalopram; Dose-Response Relati

1993
Ritanserin decreases alcohol intake in chronic alcoholics.
    Lancet (London, England), 1991, Jan-05, Volume: 337, Issue:8732

    Topics: Adult; Affect; Alcoholism; Humans; Male; Middle Aged; Piperidines; Ritanserin; Serotonin Antagonists

1991
The 5-hydroxytryptamine stimulated formation of inositol phosphate is inhibited in platelets from alcoholics.
    Life sciences, 1988, Volume: 42, Issue:4

    Topics: Adult; Alcoholism; Blood Platelets; Humans; Inositol Phosphates; Male; Middle Aged; Piperidines; Rec

1988