INTERVENTIONALCOMPLETEDNCT01020019

A Randomized, Double-Blind, Placebo-Controlled Study of Lofexidine and Dronabinol for the Treatment of Marijuana Dependence

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2019-04-24

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2, PHASE3
Enrollment: 156 (ACTUAL)
Start date: 2010-01
Sponsor: New York State Psychiatric Institute
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Present in registry snapshot

Cannabis use disorders remain the most common illicit drug use disorder and options for treatment remain limited. Compared to other abusable substances, there has been little investigation of pharmacotherapies for cannabis dependence and no effective pharmacotherapy for cannabis dependence has yet to been developed. The development of effective cannabis dependence pharmacotherapy is an important unmet public health need. Agonist pharmacotherapy strategies have been effective for other substance use disorders (e.g., opioid and nicotine use disorders) and the endocannabinoid system represents a promising target for agonist pharmacotherapy with dronabinol. Lofexidine, a noradrenergic system suppressant, is effective in treating opioid withdrawal and shows promise as a cannabis use disorder pharmacotherapy. Haney et al. (2008) found that the combination of lofexidine and dronabinol (Lofex-Dro) was superior to placebo, lofexidine alone, or dronabinol alone in improving sleep and other cannabis withdrawal symptoms. Further, reduction in craving and relapse was greater for this combined pharmacotherapy relative to either medication alone or placebo. The proposed protocol is a 2 group, double blind, placebo-controlled outpatient study of the safety and efficacy of the combination of dronabinol and lofexidine for the treatment of cannabis dependence. We plan to enroll 180 subjects in a 12-week trial. The primary hypothesis is that dronabinol will act as an agonist treatment while lofexidine will suppress craving- and cue-induced related stress such that the combination will act in a complementary manner to induce prolonged abstinence from marijuana.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

Delta(9)-tetrahydrocannabinol

Medicines

DRONABINOL DRONABINOL DRONABINOL DRONABINOL MARINOL Marinol MARINOL

Interventions

What was registered

DRUG

Dronabinol

Dronabinol: 20 mg/TID

Marinol

DRUG

Placebo

Placebo control

DRUG

Lofexidine

Lofex: .6 mg/ TID

Source-reported results

Results posted to the registry

1 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 1
Secondary outcomes: 0
Statistical analyses: 0
Adverse-event terms: 26

PRIMARY21 Days of Consecutive Abstinence as Measured by the Time-line Followback.

Time frame: reported daily for 12 weeks/ or study participation
Measure: NUMBER · participants
Reporting status: POSTED

Group	N	Value	Spread / interval
Placebo	61	18	-
Lofexidine and Dronabinol	61	17	-

Participant flow1 period

The study included a one-week placebo lead-in phase. Participants were randomized at the end of the placebo lead-in phase and those who reported marijuana use less than once a week during the lead-in phase were considered placebo responders and were not randomized. A total of 34 participants discontinued prior to randomization for various reasons.

Overall Study

Milestone	Placebo	Lofexidine and Dronabinol
STARTED	61	61
COMPLETED	35	32
NOT COMPLETED	26	29

Why participants did not complete

Lost to Follow-up: Placebo 21 · Lofexidine and Dronabinol 18
Adverse Event: Placebo 1 · Lofexidine and Dronabinol 5
not interested in treatment: Placebo 4 · Lofexidine and Dronabinol 4

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Not accepted

Inclusion criteria

1. Men and women between the ages of 18-60 who meet DSM-IV criteria for current marijuana dependence 2. 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. 3. Individual must describe marijuana as their primary drug of abuse. 4. Individuals must be capable of giving informed consent and capable of complying with study procedures.

Exclusion criteria

1. 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. 2. Individuals who are medically unstable based on laboratory tests, electrocardiogram, medical history, physical examination that would make participation hazardous 3. Individuals with liver enzyme function tests greater than three times normal 4. Individuals with a history of seizure disorder 5. Individuals with current suicidal risk. 6. Individuals who are cognitively impaired 7. Bradycardia (\< 50 beats/minute), hypotension (sitting or standing BP \< 90/50), or symptoms attributable to low BP (i.e. lightheadedness or dizziness on standing). 8. 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. 9. Individuals who are physiologically dependent on any other drugs (excluding nicotine) that would require a medical intervention 10. Individuals with known sensitivity to dronabinol or lofexidine 11. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms 12. Individuals currently being treated with an alpha-2 agonist antihypertensive medication 13. Individuals currently being prescribed a psychotropic medication (including sleep medication). However, medication for depression is allowed if stable for at least 1 month. 14. Individuals who have a job that even mild intoxication would be hazardous (e.g., firefighter, bus driver) 15. Individuals who are court-mandated to treatment.

primary outcomes

primary measures

21 Days of Consecutive Abstinence as Measured by the Time-line Followback.

Time frame: reported daily for 12 weeks/ or study participation

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 8d8e70ae-15fb-4148-9050-f722af29ebdc
Retrieved: 11/09/2026, 14:54:39
SHA-256: 6ace1f141d04b4240176607ddecbe1a6872f2972b93b38e40f1551d0f7b7493d

Event	System	Groups: affected / at risk
abdominal pain	Gastrointestinal disorders	Placebo: 0 / 61 · Lofexidine and Dronabinol: 1 / 61
detoxification	Psychiatric disorders	Placebo: 1 / 61 · Lofexidine and Dronabinol: 0 / 61

Event	System	Groups: affected / at risk
dry mouth	General disorders	Placebo: 6 / 61 · Lofexidine and Dronabinol: 27 / 61
fatigue	General disorders	Placebo: 15 / 61 · Lofexidine and Dronabinol: 26 / 61
dizzy	General disorders	Placebo: 12 / 61 · Lofexidine and Dronabinol: 21 / 61
insomnia	General disorders	Placebo: 13 / 61 · Lofexidine and Dronabinol: 13 / 61
intoxication	General disorders	Placebo: 2 / 61 · Lofexidine and Dronabinol: 13 / 61
headache	General disorders	Placebo: 12 / 61 · Lofexidine and Dronabinol: 10 / 61
anxiety	Psychiatric disorders	Placebo: 11 / 61 · Lofexidine and Dronabinol: 3 / 61
hypotension	Vascular disorders	Placebo: 1 / 61 · Lofexidine and Dronabinol: 10 / 61
drowsiness	General disorders	Placebo: 4 / 61 · Lofexidine and Dronabinol: 9 / 61
upper respiratory infection	Respiratory, thoracic and mediastinal disorders	Placebo: 8 / 61 · Lofexidine and Dronabinol: 2 / 61
nausea	Gastrointestinal disorders	Placebo: 5 / 61 · Lofexidine and Dronabinol: 6 / 61
irritability	General disorders	Placebo: 6 / 61 · Lofexidine and Dronabinol: 3 / 61
decreased appetite	Metabolism and nutrition disorders	Placebo: 6 / 61 · Lofexidine and Dronabinol: 2 / 61
sweating	Skin and subcutaneous tissue disorders	Placebo: 5 / 61 · Lofexidine and Dronabinol: 5 / 61
depression	Psychiatric disorders	Placebo: 5 / 61 · Lofexidine and Dronabinol: 3 / 61
stomache upset	Gastrointestinal disorders	Placebo: 5 / 61 · Lofexidine and Dronabinol: 2 / 61
diarrhea	Gastrointestinal disorders	Placebo: 4 / 61 · Lofexidine and Dronabinol: 2 / 61
vomitting	Gastrointestinal disorders	Placebo: 4 / 61 · Lofexidine and Dronabinol: 2 / 61
fever	General disorders	Placebo: 4 / 61 · Lofexidine and Dronabinol: 1 / 61
orthostasis	Vascular disorders	Placebo: 1 / 61 · Lofexidine and Dronabinol: 4 / 61
sore throat	General disorders	Placebo: 3 / 61 · Lofexidine and Dronabinol: 2 / 61
gas	Gastrointestinal disorders	Placebo: 1 / 61 · Lofexidine and Dronabinol: 3 / 61
confusion	Nervous system disorders	Placebo: 1 / 61 · Lofexidine and Dronabinol: 3 / 61
rash	Skin and subcutaneous tissue disorders	Placebo: 3 / 61 · Lofexidine and Dronabinol: 0 / 61

A Randomized, Double-Blind, Placebo-Controlled Study of Lofexidine and Dronabinol for the Treatment of Marijuana Dependence

Registry results are available

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

Dronabinol

Placebo

Lofexidine

Results posted to the registry

Overall Study

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

21 Days of Consecutive Abstinence as Measured by the Time-line Followback.

Locally readable linked articles

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Placebo

Lofexidine and Dronabinol