Second-line Medications

The Public Health Service Guideline recommends two medications (clonidine and nortriptyline) as second-line choices in the treatment of tobacco dependence. Second-line medications should be considered for smoking cessation under a physician’s direction.

Second-line medications have a more limited role than first-line medications because:

• The FDA has not approved them for a tobacco dependence treatment indication.
• There are more concerns about potential side effects.

Second-line medication treatments should be considered for use on a case-by-case basis after first-line treatments have been used or considered.

Prescription Only Drugs

Both second-line medications (clonidine and nortriptyline) require a prescription from a licensed health professional.

Clonidine

Clonidine is used primarily as an antihypertensive medication (Fiore et al., 2000). Clonidine has not been approved by the FDA as an aid to smoking cessation (Fiore et al., 2000). Before advising tobacco users to quit with Clonidine, review the Treatment Specialist's role.

Dosages studied vary from 0.1 to 0.75 mg/day:

• Clonidine tablet:       0.15 - 0.75 mg/day by mouth
• Clonidine Patch:      0.10 - 0.20 mg/day transdermal

Presentation

Clonidine is available as a tablet and as a transdermal patch

Availability

Brand name:

• Oral:  Clonidine (generic); Catapres Tablets
• Transdermal:  Catapres-TTS Transdermal Patch

Dosage and Duration

• Do not stop taking this medication suddenly.
• Gradually reduce the dose over a period of 2-4 days.

Clonidine tablet:

Initial dose is typically 0.10 mg twice a day by mouth.
Dose duration ranges from 3-10 weeks.

Clonidine patch (TTS):          

Use one patch per week.
Initial dose is typically 0.10 mg/day TTS.
Dose duration ranges from 3-10 weeks.

Efficacy

Odds ratio 2.1 (clonidine: placebo)

Meta-analysis data show that in placebo-controlled double-blind studies, tobacco users were 2.1 times more likely to quit successfully using clonidine (Fiore et al., 2000).

Precautions

People should talk to their doctor before using clonidine. Tobacco users in any of the special circumstances groups should consult with a physician before taking clonidine.  Discuss any troublesome side effects with a doctor.

People should not use clonidine if they have the following conditions:

• Hypersensitivity (skin allergy to adhesives).
• Heart or blood vessel disease.
• Stroke.
• Mental depression or history of mental depression.
• Kidney disorders.
• Pregnant/breast-feeding.
• Adolescents (under 18 years of age).
• Taking beta-blockers and tricyclic antidepressants.
• Raynaud's disease.
• Systemic lupus erythematosus (SLE) (with transdermal system [skin patch] only) (“Clonidine,” 2000; Fiore et al., 2000).

Clonidine may cause side effects, including:

• Dry mouth
• Drowsiness
• Dizziness
• Sedation
• Constipation
• Slow heartbeat, because it is used to treat high blood pressure

(“Clonidine,” 2000; Fiore et al., 2000)

Instructions for use

The person should take or apply Clonidine as directed by his or her doctor. Do not stop taking this medicine suddenly. People should gradually reduce the dose over a period of 2-4 days. Failure to do so may result in a rapid increase in blood pressure, agitation, confusion, and/or tremor
(Fiore et al., 2000).

Initiate clonidine shortly before (up to 3 days), or on, the quit date. At the start of each week, the tobacco user should place a new patch on a relatively hairless location between the neck and waist (Fiore et al., 2000).

Store at room temperature (59° to 86° F) away from moisture and sunlight. Do not store in the bathroom. Keep in a tightly closed container and out of reach of children.

Cost/day

Clonidine Tablet:                       $0.24 for 0.2 mg.
Catapres (transdermal patch):    $3.50
(Fiore et al., 2000)