Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01190085 · ClinicalTrials.gov registry record · NA
Effects of Ghrelin on Alcohol Cue Reactivity and Craving
A NA study, sponsored by Brown University.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT01190085: Completed NA study, sponsored by Brown University.
NCT01190085 is a NA study that has completed, run by Brown University. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01190085, a NA study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study Summary
Only a few medications are approved for the treatment of alcohol dependence and there exists a substantial need for discovering ways to provide more effective treatments. Accordingly, identifying new potential neuropharmacological targets in the treatment of alcohol dependence represents a high priority in public health. Ghrelin is a 28-amino acid peptide acting as the endogenous ligand for the growth hormone secretagogue receptor (GHS-R). Ghrelin was first isolated from the stomach, but a central hypothalamic production of ghrelin has also been demonstrated. Ghrelin plays a key role in the regulation of appetite. Consistent with the common neurobiological substrates for control of food and alcohol consumption, preclinical investigations suggest that ghrelin plays a role in the neurobiology of alcohol dependence, thus representing a new potential neuropharmacology target. In keeping with the preclinical studies, human investigations showed that alcohol consumption affects blood ghrelin levels and that blood ghrelin levels significantly and positively correlate with craving measurements in alcohol-dependent individuals. The effects of exogenous ghrelin injected intravenous (i.v.) in alcohol-dependent individuals, however, have never been investigated. The current project proposes a randomized double-blind placebo-controlled 3-group between-subject laboratory study aimed at investigating the effects of exogenous ghrelin i.v. on non-treatment seeking alcohol-dependent subjects in terms of urges to drink, attention to cues and related psychophysiological measures. This project has the goals to: i) conduct an alcohol laboratory study testing the role of ghrelin i.v., therefore demonstrating the feasibility of such a study and the safety of ghrelin i.v. when administered to alcohol-dependent individuals; and ii) explore the effects of ghrelin i.v. on alcohol craving assessed under controlled conditions, such as a cue-reactivity (CR) experiment. This study will address wh
Primary Outcome
Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of urge to drink \[as measured by the Alcohol Visual Analogue Scale (A-VAS)\]. The A-VAS was rated on 11-point anchored Likert-type scales, where 0 is the minimum score (no craving) and 11 is the maximum score (highest craving intensity). The change in the A-VAS score (deltaA-VAS) was used to indicate decrease (-d) or increase (+d) in cravi
Interventions
- DRUG Saline solution
- DRUG Ghrelin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2011-04 |
| Phase | NA |
What the finished NCT01190085 record still lists
NCT01190085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline solution is the first listed.
NCT01190085 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01190085 about?
NCT01190085 is a clinical study titled "Effects of Ghrelin on Alcohol Cue Reactivity and Craving". Only a few medications are approved for the treatment of alcohol dependence and there exists a substantial need for discovering ways to provide more effective treatments. Accordingly, identifying new potential neuropharmacological targets in the treatment of alcohol dependence represents a high prio...
What is the current status of trial NCT01190085?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2011-04.
What interventions are being tested in trial NCT01190085?
The interventions under investigation include: Saline solution (DRUG), Ghrelin (DRUG).
Who is sponsoring clinical trial NCT01190085?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01190085's enrollment target sits among peer trials
45 1411th of 2000 higher than 578 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia