Phase 3
N=122
Combined Pharmacotherapy for Cannabis Dependency
Cannabis Dependence · Marijuana Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01020019 ↗Enrolled (actual)
122
Serious AEs
1.6%
Results posted
May 2016
Primary outcome: Primary: 21 Days of Consecutive Abstinence as Measured by the Time-line Followback. — 18; 17 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dronabinol (Drug); Placebo (Drug); Lofexidine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 21 Days of Consecutive Abstinence as Measured by the Time-line Followback. |
18; 17 | — |
Summary
The purpose of this study is to see if Lofexidine in combination with Marinol is superior to placebo in achieving abstinence, reducing cannabis use and reducing withdrawal in cannabis-dependent patients seeking treatment for their marijuana use.
Eligibility Criteria
Inclusion Criteria
- Men and women between the ages of 18-60 who meet DSM-IV criteria for current marijuana dependence
- Individuals must report using marijuana at least 5 days a week and have a positive urine test for THC on the day of study entry.
- Individual must describe marijuana as their primary drug of abuse.
- Individuals must be capable of giving informed consent and capable of complying with study procedures.
Exclusion Criteria
- Meets DSM-IV-TR criteria for schizophrenia, schizoaffective illness, psychotic disorder other than transient psychosis due to drug abuse, major depression, bipolar illness or psychiatric disorders (other than substance abuse) which require psychiatric intervention.
- Individuals who are medically unstable based on laboratory tests, electrocardiogram, medical history, physical examination that would make participation hazardous
- Individuals with liver enzyme function tests greater than three times normal
- Individuals with a history of seizure disorder
- Individuals with current suicidal risk.
- Individuals who are cognitively impaired
- Bradycardia (< 50 beats/minute), hypotension (sitting or standing BP < 90/50), or symptoms attributable to low BP (i.e. lightheadedness or dizziness on standing).
- Nursing mothers and pregnant women. Women of child bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, urine pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.
- Individuals who are physiologically dependent on any other drugs (excluding nicotine) that would require a medical intervention
- Individuals with known sensitivity to dronabinol or lofexidine
- Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
- Individuals currently being treated with an alpha-2 agonist antihypertensive medication
- Individuals currently being prescribed a psychotropic medication (including sleep medication). However, medication for depression is allowed if stable for at least 1 month.
- Individuals who have a job that even mild intoxication would be hazardous (e.g., firefighter, bus driver)
- Individuals who are court-mandated to treatment.
Data sourced from ClinicalTrials.gov (NCT01020019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.